Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry

Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry


Andrew E. Waters,1 Tania Contente-Cuomo,1 Jordan Buchhagen,1 Cindy

M. Liu,1,2 Lindsey Watson,1 Kimberly Pearce,1 Jeffrey T. Foster,2

Jolene Bowers,1 Elizabeth M. Driebe,1 David M. Engelthaler,1 Paul

S. Keim,1,2 and Lance B. Price1

1Division of Pathogen Genomics, Translational Genomics Research Institute, and

2Center for Microbial Genetics and Genomics, Northern Arizona University,

Flagstaff, Arizona

We characterized the prevalence, antibiotic susceptibility profiles, and genotypes of Staphylococcus aureus among US meat and poultry samples (n 5 136). S. aureus contaminated 47% of samples, and multidrug resistance was common among isolates (52%). S. aureus genotypes and resistance profiles differed significantly among sample types, suggesting food animal–specific contamination.

Antimicrobials are used extensively in food animal production, where they are often applied subtherapeutically for growth promotion and routine disease prevention [1]. Surveys conducted by the National Antimicrobial Resistance Monitoring System (NARMS) indicate that retail meat and poultry products are frequently contaminated with multidrug-resistant Campylobacter species, Salmonella species, Enterococcus species, and Escherichia coli [2]; but little is known about the prevalence of other antibiotic-resistant pathogens in the US food supply. Staphylococcus aureus is among the most prevalent causes of clinical infections globally and has garnered substantial public attention due to increasing mortality associated with multidrug resistance. A new multidrug-resistant S. aureus strain, ST398, has emerged that predominantly colonizes people working in food animal production. First discovered in 2003, ST398 now makes up a substantial proportion of the community-acquired methicillin-resistant S. aureus (MRSA) cases in the Netherlands [3]. Multiple studies have demonstrated the high prevalence of multidrug-resistant S. aureus, including ST398, among intensively raised swine in the European Union, Canada, and the United States [4, 5], but few studies have been conducted to measure its prevalence in US food products [6]. In the current study, we evaluated the prevalence and antibiotic susceptibility profiles of S. aureus in retail meat and poultry samples from 5 US cities. We found that S. aureus contamination was common among the samples and that distinct S. aureus populations were associated with each meat and poultry type. We further demonstrated the prevalence of multidrug resistance, including resistance to clinically important antibiotics such as ciprofloxacin, quinupristin/dalfopristin, clindamycin, erythromycin, oxacillin, and daptomycin.

snip...

Our data demonstrate that retail meat and poultry are frequently contaminated with multidrug-resistant S. aureus, but the public health relevance of this finding is unclear. European and North American studies indicate that ST398 can successfully colonize and infect humans [4, 10], but few studies have investigated the risk of human colonization and infection with S. aureus from meat and poultry products [11, 12]. The European Food Safety Authority (EFSA) concluded that the risk for MRSA infection from food handling and consumption was low; however, this was based on a small number of studies [11]. Furthermore, EFSA did not evaluate the risk from methicillinsusceptible multidrug-resistant S. aureus, which is more common than MRSA among food samples.

Conventional concentrated animal feeding operations (CAFOs) provide all the necessary components for the emergence and proliferation of multidrug-resistant zoonotic pathogens. In the United States, billions of food animals are raised in densely stocked CAFOs, where antibiotics are routinely administered in feed and water for extended periods to healthy animals [1]. NARMS has shown that multidrug-resistant E. coli and Enterococcus species are prevalent among US meat and poultry products [2]. Our findings indicate that multidrug-resistant S. aureus should be added to the list of antimicrobial-resistant pathogens that routinely contaminate our food supply.


http://cid.oxfordjournals.org/content/early/2011/04/14/cid.cir181.full.pdf+html





Study Title: Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry Study


Abstract: We characterized the prevalence, antibiotic susceptibility profiles, and genotypes of Staphylococcus aureus among US meat and poultry samples (n = 136). S. aureus contaminated 47% of samples, and multidrug resistance was common among isolates (52%). S. aureus genotypes and resistance profiles differed significantly among sample types, suggesting food animal–specific contamination.


From press release:


Drug-resistant strains of Staphylococcus aureus, a bacteria linked to a wide range of human diseases, are present in meat and poultry from U.S. grocery stores at unexpectedly high rates, according to a nationwide study by the Translational Genomics Research Institute (TGen).

Nearly half of the meat and poultry samples—47 percent—were contaminated with S. aureus, and more than half of those bacteria—52 percent—were resistant to at least three classes of antibiotics, according to the study published April 15 in the journal Clinical Infectious Diseases.

This is the first national assessment of antibiotic resistant S. aureus in the U.S. food supply. And, DNA testing suggests that the food animals themselves were the major source of contamination.

Although Staph should be killed with proper cooking, it may still pose a risk to consumers through improper food handling and cross-contamination in the kitchen.

Researchers collected and analyzed 136 samples—covering 80 brands—of beef, chicken, pork and turkey from 26 retail grocery stores in five U.S. cities: Los Angeles, Chicago, Fort Lauderdale, Flagstaff and Washington, D.C.

“For the first time, we know how much of our meat and poultry is contaminated with antibiotic-resistant Staph, and it is substantial,” said Lance B. Price, Ph.D., senior author of the study and Director of TGen’s Center for Food Microbiology and Environmental Health.

“The fact that drug-resistant S. aureus was so prevalent, and likely came from the food animals themselves, is troubling, and demands attention to how antibiotics are used in food-animal production today,” Dr. Price said.

Densely-stocked industrial farms, where food animals are steadily fed low doses of antibiotics, are ideal breeding grounds for drug-resistant bacteria that move from animals to humans, the report says.

“Antibiotics are the most important drugs that we have to treat Staph infections; but when Staph are resistant to three, four, five or even nine different antibiotics—like we saw in this study—that leaves physicians few options,” Dr. Price said.

“The emergence of antibiotic-resistant bacteria—including Staph—remains a major challenge in clinical medicine,” said Paul S. Keim, Ph.D., Director of TGen’s Pathogen Genomics Division and Director of the Center for Microbial Genetics and Genomics at Northern Arizona University (NAU).

“This study shows that much of our meat and poultry is contaminated with multidrug-resistant Staph. Now we need to determine what this means in terms of risk to the consumer,” said Dr. Keim, a co-author of the paper.

The U.S. government routinely surveys retail meat and poultry for four types of drug-resistant bacteria, but S. aureus is not among them. The paper suggests that a more comprehensive inspection program is needed.

S. aureus can cause a range of illnesses from minor skin infections to life-threatening diseases, such as pneumonia, endocarditis and sepsis.

The study was supported through a grant from The Pew Charitable Trusts as part of The Pew Campaign on Human Health and Industrial Farming.

Study Information: Andrew E. Waters, Tania Contente-Cuomo, Jordan Buchhagen, Cindy M. Liu, Lindsey Watson, Kimberly Pearce, Jeffrey T. Foster, Jolene Bowers, Elizabeth M. Driebe, David M. Engelthaler, Paul S. Keim, and Lance B. Price. Multidrug-Resistant Staphylococcus aureus in US Meat and Poultry Clinical Infectious Diseases 2011 April Center for Microbial Genetics and Genomics, Northern Arizona University, Flagstaff, Arizona.

Full Study: http://cid.oxfordjournals.org/content/early/2011/04/14/cid.cir181.full.pdf+html





ALSO, see ;



Thursday, August 12, 2010

Escherichia coli sequence type ST131 as the major cause of serious multidrug-resistant E. coli infections in the United States

Clin Infect Dis. 2010 Aug 1;51(3):286-94.


http://staphmrsa.blogspot.com/2010/08/escherichia-coli-sequence-type-st131-as.html




Staphylococcus toxin is not markedly affected by heating or freezing as it is heat stable. Even if the food is heated before eating, the poison in the food will cause illness although the heat has killed the bacterial cells.




http://www.foodscience.caes.uga.edu/extension/documents/FoodPoisoning-FoodInfection.pdf




Do all toxins in food survive the cooking process?



No, all toxins in food do not survive the cooking process. In fact, the botulism toxin caused by Clostridium botulinum can be inactivated by cooking. Boiling food for 10 minutes eliminates this toxin. However, many other toxins are heat stable. For example, Staphylococcus can produce toxins that are not destroyed by high cooking temperatures. To prevent toxins from developing in food, don"t leave food sitting out at room temperature for more than 2 hours. On a hot day (90° F or higher), food should not sit out for more than 1 hour.



http://www.gchd.org/NFSEM/a2z-t.html




The toxin produced by staph bacteria is very heat-stable – so it is not easily destroyed by heat at normal cooking temperatures. The bacteria may be killed, but the toxin remains. Careful handling of food that is prepared ahead of serving is important. This is especially important with foods left over after one meal and planned to be used again at a later meal. Quick cooling and refrigeration, or holding at or above 140ºF, can help ensure that toxin has no chance to be formed.



http://www.summitcountyhealth.org/food-service/foodborne-illness/staph-infection/





The toxin produced by staph bacteria is very heat-stable - it is not easily destroyed by heat at normal cooking temperatures. The bacteria themselves may be killed, but the toxin remains. Careful handling of food that is prepared ahead is important. This is especially important of foods left over after one meal and planned to be used again at a later meal. Quick cooling and refrigeration, or holding at or above 140 degrees F, can help ensure that toxin has no chance to be formed.



http://ohioline.osu.edu/hyg-fact/5000/5564.html




Wednesday, April 14, 2010

FSIS National Residue Program for Cattle Audit Report 24601-08-KC March 2010 U.S. Department of Agriculture Office of Inspector General


http://staphmrsa.blogspot.com/2010/04/fsis-national-residue-program-for.html





Thursday, February 11, 2010

Denmark's Case for Antibiotic-Free Animals NEW YORK, Feb. 10, 2010


http://staphmrsa.blogspot.com/2010/02/denmarks-case-for-antibiotic-free.html





also see ;


http://staphmrsa.blogspot.com/2008/03/iceid-2008-methicillin-resistant.html



http://staphmrsa.blogspot.com/



update 4/28/11



10 PATHOGEN-FOOD COMBINATIONS RANKING THE HEALTH RISK (TITLE TO RANCHERS)




Ranking the Risks: The 10 Pathogen-Food Combinations With The Greatest Burden on Public Health



Michael B. Batz, Sandra Hoffmann and J. Glenn Morris, Jr.



http://www.epi.ufl.edu/sites/www.epi.ufl.edu/files/RankingTheRisksREPORT.pdf




if this is what feeding the masses has come to, count me out ;




http://www.bloggernews.net/126457




update 4/21/11



Cache Creek Dairy 4/6/11




Department of Health and Human Services Public Health Service Food and Drug Administration San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701



UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED



Our Reference: 3006172673



WARNING LETTER



April 6, 2011



Mr. Jack Kasbergen, Co-Owner Mrs. Ellie M. Kasbergen, Co-Owner Cache Creek Dairy 31503 County Road 26 Woodland, California 95695



Dear Mr. & Mrs. Kasbergen:



On February 1, 2, and 10, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 31503 County Road 26, Woodland, California. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about May 27, 2010, you sold a dairy cow, identified with ear tag (b)(4) , for slaughter as food. On or about May 28, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 0.431 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.



For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).



We also found that you adulterated the new animal drugs sulfadimethoxine (b)(4) and flunixin meglumine (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine and flunixin meglumine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered sulfadimethoxine to one of your dairy cows identified with ear tag (b)(4) without following the dose and route of administration as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Our investigation also found that you administered flunixin to one of your dairy cows identified with ear tag [b4] without following the route of administration as stated in its approved labeling. Your extralabel use of flunixin was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.



Sincerely,



/s/



Barbara J. Cassens District Director San Francisco District U. S. Food and Drug Administration



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm250770.htm





March 28, 2011



WARNING LETTER



CERTIFIED MAIL RETURN RECEIPT REQUESTED Refer to MIN 11 - 18



James B. Drake President and Co-owner Drake Dairy, Inc. N8870 Drake Court Elkhart Lake, Wisconsin 53020



Dear Mr. Drake:



On January 25 and February 14, 2011, the Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at N8870 Drake Court, Elkhart Lake, Wisconsin. This letter notifies you of violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about September 17, 2010, you consigned (b)(4) to haul your dairy cow (ear tag# (b)(4) indentified with back tag # (b)(4) for slaughter as food. On or about September 17, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of ampicillin at 0.33 parts per million (ppm) in kidney. The FDA has established a tolerance of 0.01 ppm for ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.40, 21 CFR 556.40. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to have an effective system to control administration of drug treatments to your animals. Herdsmen have been authorized to administer drugs; but they failed to relay treatment information to the herd manager. You also failed to maintain complete treatment records that include the drug, dosage, route of administration, and withholding period to ensure that treated cattle are not culled before labeled meat and milk withhold times are met. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).



In addition to the above violation, we are concerned that USDA/FSIS identified another recent tissue residue associated with your dairy operation. Illegal levels of ampicillin and flunixin were found on October 20, 2009, in your dairy cow with ear tag #(b)(4) (back tag (b)(4).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute are in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



We received an unsigned letter dated October 26, 2010, from Drake Dairy. The letter was post-marked February 17, 2011, and received in our office on February 22, 2011. The letter states that you have taken steps to help ensure that drug residue violations will not happen in the future. You made changes in your treatment protocols and record keeping, established a new communication system between the Herdsman and the Herd Manager, and are now entering all treatments into the (b)(4) computer system. We consider these to be necessary and appropriate corrective actions. However, your letter did not provide documentation that corrections have been implemented. Within 15 working days of receiving this letter, please provide our office with further documentation to substantiate your corrections. For example, provide copies of a representative sample of treatment records and any other records demonstrating that corrections have been made.



Your written response should be sent to Timothy G. Philips, Compliance Officer, Food and Drug Administration, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Philips at (612) 758-7133.



Sincerely, /S/ Gerald J. Berg Director Minneapolis District



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm249410.htm





Van Es Dairy 3/25/11



Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District Pacific Region 22201 23rd Drive SE Bothell, WA 98021-4421 Telephone: 425-486-8788 FAX: 425-483-4996



March 25, 2011



CERTIFIED MAIL RETURN RECEIPT REQUESTED



In reply refer to Warning Letter SEA 11-08



Dale Van Es, Owner Van Es Dairy 8222 Desert Drive Marsing, Idaho 83639-8264



WARNING LETTER



Dear Mr. Van Es:



On December 8 and 9, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 8222 Desert Drive, Marsing, Idaho. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about June 16, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about June 18, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin in the liver tissue at 0.662 parts per million (ppm). FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).



We also found that you adulterated sulfadimethoxine and flunixin meglumine. Specifically, our investigation revealed that you did not use Albon (sulfadimethoxine) Boluses, NADA 031-715, and Prevail (flunixin meglumine) Injectable, ANADA 200-308, as directed by their approved labeling. Use of these drugs in this manner is an extralabel use, 21 C.F.R. 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered Albon (sulfadimethoxine) Boluses, NADA 031-715, to your dairy cows without following the dose as indicated in its approved labeling. Albon (sulfadimethoxine) Boluses, NADA 031-715, is prohibited from extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).



In addition, our investigation found that you administered Prevail (flunixin meglumine) Injectable, ANADA 200-308, to your dairy cows without following the dose and duration of treatment as indicated in its approved labeling. Your extralabel use of Prevail (flunixin meglumine) Injectable, ANADA 200-308, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Lisa M. Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Althar at (425) 483-4940.



Sincerely,



/s/



Charles M. Breen District Director



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm249856.htm





Zimmerman, Mark S. 3/22/11



Department of Health and Human Services Public Health Service Food and Drug Administration PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA 19106 Telephone: 215-597-4390



WARNING LETTER 11-PHI-08



CERTIFIED MAIL RETURN RECEIPT REQUESTED



March 22, 2011



Mark S. Zimmerman, Owner Mark S. Zimmerman Farm 641 Cranberry Road Martinsburg, Pennsylvania 16662



Dear Mr. Zimmerman:



On January 25, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 641 Cranberry Road, Martinsburg, Pennsylvania. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about March 1, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about March 2, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of flunixin in the liver at 0.121 parts per million (ppm). FDA has not established a tolerance for residues of flunixin in the edible tissues of veal calves. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).



We also found that you adulterated the new animal drug Flunazine (flunixin meglumine). Specifically, our investigation revealed that you did not use Flunazine (flunixin meglumine) as directed by its approved labeling. Use of this drug in this manner is an extralabel use. 21 C.F.R. 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered the new animal drug Flunazine (flunixin meglumine) to a bob veal calf, with back tag (b)(4), without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drug Flunazine (flunixin meglumine) was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



We acknowledge that you have started keeping medical treatment records for your animals. However, we do not have enough information to allow FDA to evaluate whether the referenced corrective actions are adequate.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at robin.rivers@fda.hhs.gov.



Sincerely,



/s/



Kirk D. Sooter District Director Philadelphia District



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm248149.htm





Horizon Acres 3/18/11



Department of Health and Human Services Public Health Service Food and Drug Administration Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-30977 Telephone: (513) 679-2700 FAX: (513) 679-2761



WARNING LETTER CIN-11-65585-06



March 18, 2011



United Parcel Service



Mr. Kenneth D. Weaver, General Manager Horizon Acres 6728 Zuercher Road Dalton, Ohio 44618



Dear Mr. Weaver:



On November 10, 12, 19,24, 2010, and December 20, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf operation located at 6728 Zuercher Road, Dalton, Ohio 44618. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA's web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about June 22, 2010, you sold an unidentified, untagged veal calf for slaughter as food. On or about June 22, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence 0.28 parts per million (ppm) of flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver of cattle as codified in 21 C.F.R. 556.286(b)(1)(i). However, this tolerance does not apply to use of Suppressor (flunixin meglumine) Injectable Solution, ANADA 200-308, in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with use of flunixin meglumine in veal calves (pre-ruminating calves). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records and segregate treated animals. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).



We also found that you adulterated the new animal drugs Suppressor (flunixin meglumine) ANADA 200-308, Dexamethasone ANADA 200-312, Ceftiflex sterile powder (ceftiofur sodium) ANADA 200-420, PennOne Pro (penicillin G procaine) NADA 65-010, Amoxicillin capsules NDC 65862-017-05, Sulfamethoxazole and Trimethoprim Double Strength tablets NDC 53746-272-05 (SMZ-TMP tablets), and Pennchlor 64 (chlortetracycline HCI) ANADA 200-295. Specifically, our investigation revealed that you did not use these drugs as directed by their approved labeling. Use of these drugs in this manner is an extralabel use. 21 C.F.R. § 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered flunixin meglumine to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(c).



Our investigation found that you administered dexamethasone to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of Dexamethasone was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a).



Our investigation found that you administered ceftiofur sodium to veal calves without following the withdrawal period as stated in the approved labeling. Your extralabel use of ceftiofur sodium was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).



Our investigation found that you administered penicillin G procaine to veal calves without following the route of administration and the withdrawal period as stated in the approved labeling. Your extralabel use of penicillin G procaine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11(a).



Our investigation found that you administered amoxicillin and sulfamethoxazole and trimethoprim (SMZ-TMP) to veal calves without following the route of administration and duration of the treatment as stated in their approved labeling. Your extralabel use of Amoxicillin and SMZ-TMP were not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. § 530.11 (a) and your use of amoxicillin and SMZ-TMP in or on feed, is in violation of 21 C.F.R. § 530.11(b).



Our investigation found that you administered chlortetracycline HCI to veal calves without following the duration of treatment. Your use of chlortetracycline HCI was not under the supervision of a licensed veterinarian, and is in violation of 21 C.F.R. § 530.11(a) and your use of pennchlor 64 in or on feed, is in violation of 21 C.F.R. § 530.11(b). Because your use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug(s) to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5).



In addition, you adulterated the liquid animal feed within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6), when you added sulfamethoxazole and trimethoprim, Amoxicillin, and chlortetracycline HCI, and you failed to use the medicated feed in conformance with its approved labeling. Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6). Section 512 of the FD&C Act, 21 U.S.C. § 360b, and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feed.



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Hunter at 513-679-2700 ext. 134.



Sincerely yours, /S/



Teresa Thompson District Director Cincinnati District



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm248212.htm





Azevedo and Sons Dairy, Inc. 3/4/11



Department of Health and Human Services Public Health Service Food and Drug Administration Seattle District



Pacific Region



22201 23rd Drive SE



Bothell, WA 98021-4421



Telephone: 425-486-8788



FAX: 425-483-4996



March 4, 2011



CERTIFIED MAIL RETURN RECEIPT REQUESTED



In reply refer to Warning Letter SEA 11-06



Lisuarte M. Azevedo, President Azevedo and Sons Dairy, Inc. 10034 Hendricks Road Othello, Washington 99344



WARNING LETTER



Dear Mr. Azevedo:



On January 5 and 13, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 10034 Hendricks Road, Othello, Washington. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov. 1



We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. § 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about July 23, 2010, you sold a cow, identified with ear tag number (b)(4) for slaughter as food. On or about July 23, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 0.801 parts per million (ppm) flunixin in the liver tissue. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the edible tissues of cows as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. § 556.286). In addition, our investigation revealed that on or before May 6, 2010, you delivered a cow identified with ear tag number (b)(4) to (b)(4). On or about May 6, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 0.755 ppm sulfadimethoxine in liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cows as codified in 21 C.F.R. § 556.640. The presence of these drugs in edible tissue from these animal in these amounts causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).



We also found that you adulterated the new animal drugs Banamine NADA # 101-479 (flunixin meglumine) and Albon NADA # 031-715 (sulfadimethoxine). Specifically, our investigation revealed that you did not use flunixin meglumine and sulfadimethoxine as directed by their approved labeling. Use of these drugs in this manner is an extralabel use as indicated in 21 C.F.R. § 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered flunixin meglumine to the cow identified with ear tag number (b)(4) without following the dose, route of administration, and withdrawal period as stated in the approved labeling. Your extralabel use of flunixin meglumine was not under the supervision of a license veterinarian, in violation of 21 C.F.R. § 530.11(a) and your extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. § 530.11(d). Our investigation also found that you administered sulfadimethoxine (Albon) to the cow identified with ear tag number (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. § 530.41(a)(9) and your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. § 530.11(d). Because your use of these drugs were not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



Our investigation also revealed that on or about May 4, 2010, and on or about August 17, 2010, you provided to (b)(4), a signed certification, that states that all animals brought to (b)(4), for sale or processing, have been handled in a manner to prevent pharmaceutical or biological residue violation. On or about July 23, 2010, you delivered a cow containing violative flunixin residue to (b)(4). Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur. You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4426. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at 425-483-4926.



Sincerely yours,



S/



Charles M. Breen District Director



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm247175.htm





Amting Dairy Farm 3/4/11



Department of Health and Human Services Public Health Service Food and Drug Administration Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139



WARNING LETTER 2011-DET-07



March 4, 2011



VIA UNITED PARCEL SERVICE



Mr. Bernardus H. Amting, Owner Amting Dairy Farm 17451 N Drive N Marshall, Michigan 49068



Dear Mr. Amting:



On December 16 and 29, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 17451 N Drive N, Marshall, Michigan. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about August 31, 2010, you sold a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), for slaughter as food. On or about September 1, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfamethazine in the liver tissue at 0.268 parts per million (ppm). FDA has established a tolerance of 0.1 ppm for residues of sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.670 (21 C.F.R. 556.670). The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).



We also found that you adulterated the new animal drugs flunixin and oxytetracycline. Specifically, our investigation revealed that you did not use Suppressor (flunixin meglumine), ANADA 200-308, and Oxytet 100 (oxytetracycline hydrochloride), ANADA 200-452, as directed by their approved labeling. Use of these drugs in this manner is an extra label use, 21 C.F.R. 530.3(a).



The extra label use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extra label use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered flunixin to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the route of administration and the withdrawal period as indicated in its approved labeling. Your extra label use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



In addition, our investigation found that you administered oxytetracycline to a dairy cow, identified with back tag (b)(4) and ear tag (b)(4), without following the withdrawal period as indicated in its approved labeling. Your extra label use of oxytetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your extra label use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



We remind you that FDA has issued you a prior Warning Letter on August 29, 2003. A copy of this Warning Letter is provided for your review and information.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Mr. Michael V. Owens, Compliance Officer, U.S. Food and Drug Administration at 300 River Place, Suite 5900 Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Michael Owens at 313-393-8167 or E-mail at michael.owens@fda.hhs.gov.



Sincerely yours,



/s/



Joann M. Givens District Director Detroit District Office



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm246193.htm





InSight Dairy, LLC. 2/24/11



Department of Health and Human Services Public Health Service Food and Drug Administration New York District



158-15 Liberty Avenue Jamaica, NY 11433



February 24, 2011



WARNING LETTER NYK-2011-18



VIA United Parcel Services



Christopher A. and Jessica A. Fredericks, Owners InSight Dairy, LLC. 682 Newville Road Little Falls, New York 13365-4614



Dear Mr. and Ms. Fredericks,



On January 4 and 6, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 682 Newville Road, Little Falls, New York 13365-4614. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale animals for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about July 19, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 20, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 12.95 parts per million (ppm) of neomycin residue in the kidney. In addition, our investigation revealed that on or about August 2, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about August 3, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of 10.53 parts per million (ppm) of neomycin residue in the kidney. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. 556.430). However, this tolerance does not apply to the use of (b)(4) in bob veal calves, and there is no acceptable level of residue associated with the use of this medicated milk replacer in veal calves. The presence of this drug in edible tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).



We also found that you adulterated the new animal drug neomycin sulfate. Specifically, our investigation revealed that you did not use neomycin sulfate as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).



Our investigation found that you fed (b)(4) containing neomycin sulfate to both bob veal calves with back tags #(b)(4) without following the approved labeling. The extralabel use of (b)(4)containing neomycin sulfate was in or on feed, in violation of 21 C.F.R. 530.11(b), and the extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because this use of (b)(4) containing neomycin sulfate was not in conformance with the approved labeling, you caused the drug in the feed to be unsafe under section 512(a)(1) of the FD&C Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5). In addition, you caused the animal feed containing the neomycin sulfate to be unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. § 360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. § 351(a)(6).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean R. Rugnetta at (716) 541-0324 or Email at Dean.Rugnetta@fda.hhs.gov.



Sincerely yours,



/S/ Ronald M. Pace District Director New York District



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm245257.htm





Jesse R. Petre Farm 2/15/11



Department of Health and Human Services Public Health Service Food and Drug Administration PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Street Philadelphia, PA 19106 Telephone: 215-597-4390



WARNING LETTER 11-PHI-06



CERTIFIED MAIL RETURN RECEIPT REQUESTED



February 15, 2011



Mr. Jesse R. Petre Farm, Owner 1215 Mason Dixon Road Greencastle, PA 17225



Dear Mr. Petre:



On January 12, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 1215 Mason Dixon Road, Greencastle, PA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale, an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about January 14, 2010, you sold a veal calf, identified with back tag (b)(4) for slaughter as food. On or about January 15, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 7.37 parts per million (ppm) of neomycin in the kidney tissue, and 0.11 ppm of flunixin in the liver tissue. FDA has established a tolerance of 7.2 ppm for neomycin, and 0.125 parts per billion (ppb) for flunixin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), (21 C.F.R. 556.430(b)(1); 556.286(b)(1)). The presence of these drugs in edible tissues from this animal in these amounts cause the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(II).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Robin M. Rivers, Compliance Officer, United States Food and Drug Administration, United States Customs House, Room 900, 200 Chestnut Street, Philadelphia, PA 19106. If you have any questions about this letter, please contact Ms. Rivers at 215-717-3076.



Sincerely,



/s/



Kirk D. Sooter District Director Philadelphia District Office



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm244595.htm





Lloyd B. Zimmerman and Sons 2/15/11



Department of Health and Human Services Public Health Service Food and Drug Administration PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Street Philadelphia, PA 19106 Telephone: 215-597-4390



WARNING LETTER 11-PHI-07



CERTIFIED MAIL RETURN RECEIPT REQUESTED



February 15, 2011



Mr. Lloyd B. Zimmerman, Owner Lloyd B. Zimmerman and Sons 2413 Snydertown Road Danville, Pennsylvania 17821-7429



Dear Mr. Zimmerman:



On October 28, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 2413 Snydertown Road, Danville, PA. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale animals for slaughter as food that were adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about May 5, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about May 5, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 15.14 parts per million (ppm). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in Title 21, Code of Federal Regulations, Section 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).



In addition, our investigation revealed that on or about July 14, 2010, you sold a bob veal calf, identified with back tag (b)(4), for slaughter as food. On or about July 14, 2010, (b)(4), slaughtered this animal. USDA/FSIS analysis of tissue samples collected from this animal identified the presence of neomycin in the kidney at 11.51 ppm. FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). However, this tolerance does not apply to the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing oxytetracycline, and neomycin in veal calves (pre-ruminating calves), and there is no acceptable level of residue associated with the use of (b)(4) Vigormilk 22BNT Medicated Milk Replacer containing Oxytetracycline, and neomycin in veal calves (pre-ruminating calves). Therefore, the presence of this drug in kidney tissue from this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).



We also found that you adulterated the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer. Specifically, our investigation revealed that you did not use (b)(4) Vigormilk 22BNT Medicated Milk Replacer as directed by its approved labeling. Use of these drugs in this manner is an extralabel use, 21 C.F.R. 530.3(a).



The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered the new animal drugs Oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer to your bob veal calves without following the animal class as stated in the approved labeling. Your extralabel use of the new animal drugs oxytetracycline, and neomycin that were contained in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and resulted in an illegal residue, in violation of 21 C.F.R. 530.11(c). Because your use of these drugs in the (b)(4) Vigormilk 22BNT Medicated Milk Replacer was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drugs to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



We are aware that you sold two bob veal calves on or about October 6, 2010, that contained 10.2 ppm of neomycin in the kidney tissue of one bob veal calf, identified with back tag (b)(4), and the presence of gentamicin in the kidney tissue of one bob veal calf, identified with back tag (b)(4). FDA has established a tolerance of 7.2 ppm for residues of neomycin in the uncooked edible kidney tissue of cattle as codified in 21 C.F.R. 556.430(b)(1). FDA has not established a tolerance for gentamicin in the edible tissues of cattle.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Robin Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at robin.rivers@fda.hhs.gov.



Sincerely,



/s/



Kirk D. Sooter District Director Philadelphia District



- http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm244555.htm





Hite's Livestock, Inc. 2/1/11



Department of Health and Human Services Public Health Service Food and Drug Administration Baltimore District Office 6000 Metro Drive, Suite 101 Baltimore, MD 21215 Telephone: (410) 779-5455 FAX: (410) 779-5707



WARNING LETTER CMS #151635



February 1, 2011



CERTIFIED MAIL RETURN RECEIPT REQUESTED



Mr. David A. Hite, Owner Hite’s Livestock, Inc. HC 34 Box 8 Bloomery, West Virginia 26817-9703



Dear Mr. Hite:



On November 29 and December 3, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your livestock operation located at HC 34 Box 8, Bloomery, West Virginia 26817-9703. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about August 22, 2010, you sold an unidentified goat for slaughter as food. On or about August 24, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of moxidectin at 0.0383 parts per million (ppm) in the liver tissue and 0.0543 ppm in the muscle tissue. FDA has not established a tolerance for residues of moxidectin in the edible tissues of goats. The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow you to withhold the animals from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues. In addition, you fail to keep accurate records of animals you buy and sell to ensure that the animals can be traced back to the producer or other dealer. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).



The violations listed above are not intended to be an all-inclusive list. It is your responsibility to assure that your operations are in compliance with the law. As a dealer of animals, you are frequently the individual who introduces or offers for introduction into interstate commerce, the adulterated animals. As such, you share responsibility for violating the Federal Food, Drug and Cosmetic Act. To avoid future illegal residue violations you should take precautions such as:



1. Implementing a system to identify the animals you purchase with records to establish traceability to the source of the animal; and



2. Implementing a system to determine from the source of the animal whether the animal has been medicated and with what drug(s); and



3. If the animal has been medicated, implementing a system to withhold the animal from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissue. If you do not want to hold the medicated animal then it should not be offered for human food, and it should be clearly identified and sold as a medicated animal.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Ms. Cherlita Honeycutt, Compliance Officer, U.S. Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions about this letter, please contact Compliance Officer Cherlita Honeycutt at (410) 779-5412 or via e-mail at Cherlita.Honeycut@fda.hhs.gov.



Sincerely yours,



/s/



Evelyn Bonnin District Director Baltimore District



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm242828.htm





Vander Schaaf Dairy #2 1/10/11



Department of Health and Human Services Public Health Service Food and Drug Administration San Francisco District Pacific Region 1431 Harbor Bay Parkway Alameda, CA 94502-7070 Telephone: 510-337-6700 FAX: 510-337-6701



UNITED PARCEL SERVICE DELIVERY SIGNATURE REQUESTED



Our Reference: 1000307183



WARNING LETTER



January 10, 2011



Mr. Earl John Vander Schaaf, Owner Vander Schaaf Dairy #2 15355 Van Allen Road Escalon, California 95320



Dear Mr. Vander Schaaf:



On September 22 and 27, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 15355 Van Allen Road, Escalon, California 95320. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov1.



We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.



Specifically, our investigation revealed that on or about April 9, 2010, you sold a dairy cow, identified with ear tag (b)(4), for slaughter as food. On or about April 10, 2010, (b)(4), slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of sulfadimethoxine at 7.068 parts per million (ppm) in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.640 (21 C.F.R. 556.640). The presence of this drug in edible tissue from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).



Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.



For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).



We also found that you adulterated the new animal drugs sulfadimethoxine (b)(4) , sulfadimethoxine (b)(4), Penicillin G Procaine (b)(4) , and Ceftiofur (b)(4). Specifically, our investigation revealed that you did not use sulfadimethoxine, penicillin G procaine, and ceftiofur as directed by its approved labeling. Use of these drugs in this manner is an extralabel use. See 21 C.F.R. 530.3(a). In addition, the extralabel use of sulfadimethoxine is prohibited in lactating dairy cows under 21 C.F.R. 530.41(a)(9).



The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.



Our investigation found that you administered sulfadimethoxine (b)(4) to one of your dairy cows identified with ear tag (b)(4) without following the dose and withdrawal period as stated in the approved labeling. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cows by 21 C.F.R. 530.41(a)(9). Furthermore, your extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



Our investigation also found that you administer sulfadimethoxine (b)(4) to your dairy cows intravenously or subcutaneously whereas the label directions indicate the drug is to be administered intravenously only. Your extralabel use of sulfadimethoxine (b)(4) was not under the supervision of a licensed veterinarian in violation of 21 C.F.R. 530.11(a). Sulfadimethoxine is prohibited for extra label use in lactating dairy cattle within 21 C.F.R. 530.41(a)(9). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



Our investigation also found that you administer penicillin G procaine injectable suspension (b)(4) to your dairy cows without following the dose as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian which is in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



Our investigation also found that you administer ceftiofur (b)(4) to your dairy cows without following the meat withdrawal period and conditions for treatment as stated in the approved labeling. Your extralabel use of ceftiofur was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).



The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.



You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.



You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.



Your written response should be sent to Karen L. Robles, Compliance Officer, Food and Drug Administration, at 650 Capitol Mall Room 8-400, Sacramento, California 95814. If you have any questions about this letter, please contact Compliance Officer Karen L. Robles at (916) 930-3674 extension 114 or via e-mail at Karen.Robles@fda.hhs.gov.



Sincerely,



/s/



Barbara J. Cassens District Director San Francisco District U. S. Food and Drug Administration



http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm239912.htm





see more here ;



http://google2.fda.gov/search?q=Animals+for+Sale+for+Slaughter+as+Food%2FAdulterated&client=FDAgov&site=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&getfields=*&x=11&y=14





TSS