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U.S. Department of Health and Human Services

Animal & Veterinary

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Warning Letters: January 2010 to April 2010

Name: Kelly Poynter, Sr., Owner, Dairy Operation
Date: 3/15/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Kelly Poynter, Sr., Owner, Dairy Operation, Cave City, KY, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, Mr. Poynter offered for sale an animal for slaughter as food that contained 35.936 parts per million (ppm) of sulfamethazine residue in the muscle tissue and the 32.294 ppm of sulfamethazine residue in the liver tissue. 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 (C.F.R.), 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 Act, 21 U.S.C. 342(a)(2)(C)(ii).  The letter also cited Mr. Poyner for having incomplete drug treatment records of the animals that are medicated, and for not using sulfamethazine as directed by its approved labeling. Use of this drug in this manner is an extra-label use.

Name: Joseph F. Brasil, President & Partner, Double B Dairy, LLC
Date: 3/8/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Joseph F. Brasil, President & Partner, Double B Dairy, LLC, Murtaugh, ID, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, Double B Dairy, LLC sold a dairy cow for slaughter as food that contained Flunixin at 1.494 parts per million (ppm) in the liver.  FDA has established a tolerance of 0.125 ppm for residues of Flunixin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.286 (21 C.F.R. 556.286). The presence of Flunixin in edible tissues 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). The Warning Letter also cited the company for having incomplete drug treatment records of the animals that are medicated.

Name:  Franciscus X.J. Van Genugten, Owner, Stardust Dairy, LLC
Date: 2/18/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Franciscus X.J. Van Genugten, Owner, Stardust Dairy, LLC, South Solon, OH, for violations of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, Stardust Dairy, LLC offered a cow for slaughter as food that contained residues of 0.1689 parts per million (ppm) of the drug Flunixin in the liver tissue.  A tolerance of 0.125 ppm in the uncooked edible tissue of cattle has been established by FDA (21 CFR 556.640) rendering the animal adulterated under section 402(a)(2)(C)(ii) of the Act. The Warning Letter also cited the company for failing to maintain an adequate inventory system (accounting and reconciliation) for determining quantities of drugs used to medicate cows and incomplete drug treatment records of the animals that are medicated.

Name: Cody G. Morgan, Owner/President, Crestview Calves, Inc.
Date: 2/16/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Cody G. Morgan, Owner/President, Crestview Calves, Inc, Hazelton, ID, for violations of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, Crestview Calves, Inc offered for sale an animal for slaughter as food that contained gentamicin sulfate in the kidney tissues. FDA has not established a tolerance for residues of gentamicin sulfate in the edible tissues of cattle. The presence of this drug in edible tissue from these animals 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).  The Warning Letter also cited the company for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply and for adulterating the new animal drug gentamicin sulfate.  Specifically, the company did not use gentamicin sulfate as directed by the veterinarian's prescription labeling nor as directed by its approved labeling. Use of this drug in this manner is an extralabel use.   

Name: Christian M. Huyard, Owner
Date: 2/12/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Christian M. Huyard, Owner, Christiana, PA, for violations of the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, Christian M. Huyard sold an animal for slaughter as food that was adulterated with unsafe levels of penicillin in the kidney and liver tissues and unsafe levels of flunixin in the liver tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the uncooked edible tissues of cattle as codified in Title 21, CFR, Section 556.510.(21 C.F.R. 556.510) and a tolerance of 0.125 ppm (or 125 parts per billion) for residues of flunixin in the liver (the target tissue) of cattle as codified in 21 C.F.R. 556.286. The presence of this drug in edible tissues from this animal in these amounts 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). The Warning Letter also cited Christian M. Huyard for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply, and that the drugs flunixin and penicillin were not used as directed by their approved labeling.

Name: Christopher T. Rangen, President, Rangen, Inc.
Date: 2/11/2010
Reason: Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded

A Warning Letter was issued to Christopher T. Rangen, President, Rangen, Inc, Buhl, ID for deviations from the requirements set forth in Title 21, Code of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000), Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of Bovine Spongiform Encephalopathy (BSE).  Specifically, the firm failed to provide for and use cleanout procedures or other means adequate to prevent carry-over of products that contain or may contain proteins derived from mammalian tissues into animal feed that may be used for ruminants, as required by 21 CFR 589.2000(e)(1)(iii)(B). Since the feed is prepared, packed, or held under these conditions it is, therefore, adulterated under section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). The firm also failed to label all products which contained or may have contained proteins derived from mammalian tissues with the statement, "Do not feed to cattle or other ruminants," as required by 21 C.F.R. 589.2000(e)(1)(i). Such products are misbranded under Section 403(a)(1) of the Act, 21 U.S.C. § 343(a)(1). The misbranded product includes bulk mink feed.

Name: Mr. Peter Bouma, Dairy Partner, & Mr. Sam Dekruyf, Dairy Partner, P&D Dairy
Date: 2/9/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Peter Bouma and Mr. Sam Dekruyf, Dairy Partners, P&D Dairy, Chino, CA for violating the Federal Food, Drug, and Cosmetic Act (the Act).  Specifically, the company offered for sale an animal for slaughter as food that was adulterated with the presence of 1.177 parts per million (ppm) of sulfadimethoxine residue in the liver.  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.) 556.640 (21 C.F.R. 556.640).  The Warning Letter also cited the company for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.  For example, the company did not maintain complete treatment records.  Also, the Warning Letter cited the company for adulterating the new animal drug penicillin G procaine (Injectable Suspension). Specifically, the investigation revealed that the company did not use penicillin G procaine 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).

Name: Barry Lynn Skaggs, DVM, President, Boonesboro Animal Clinic Corporation
Date: 1/14/2010
Reason: Extralabel Drug Use in Animals/Adulterated

A Warning Letter was issued to Barry Lynn Skaggs, DVM, President, Boonesboro Animal Clinic Corporation in response to an investigation regarding the use of drugs in this veterinary practice. The investigation revealed that a veterinarian in Dr. Skaggs’ practice, Dr. Clifton Rex Smith, caused the new animal drug, phenylbutazone, to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 360b(a)] and adulterated within the meaning of section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5)] because the drug was used in a manner that did not conform with its approved uses or with the regulations for Extra-label Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530). Specifically, Dr. Smith’s prescription for extra-label use of this drug did not meet the requirements of 21 CFR 530.12(b), (c), & (e) which require that any animal drug prescribed and dispensed for Extra-label use by a veterinarian shall bear or be accompanied by labeling information adequate to assure the safe and proper use of the product. The required labeling information includes: (1) The established name of the drug. (2) Any directions for use specified by the veterinarian, including the identification of the animal, condition to be treated, dosage, frequency, route of administration, and duration of therapy. (3) The veterinarian's specified withdrawal time for meat which might be derived from the treated animal. Dr. Smith’s prescription for extra-label use also did not meet the requirements of 21 CFR 530.20(a)(2)(iii) and (iv), which require that prior to prescribing or dispensing an approved new animal drug for an Extra-label use in food animals, the veterinarian must: (1) Institute procedures to assure that the identity of the treated animal is carefully maintained. (2) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal residues occur in any food-producing animals subject to Extra-label treatment.