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U.S. Department of Health and Human Services

Animal & Veterinary

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Warning Letters - June 30 to October 28, 2010

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 Cover of Warning Letters - June 30 to October 28, 2010

Editor's Note: The following is in date order, with the most recent first. For the complete Warning Letter, go to FDA Warning Letters.

Name: William P. Wright, Jr., President
Date: 10/28/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. William P. Wright, Jr., President, Wright Family Dairy, Baxley, GA, for violations of the Federal Food Drug, and Cosmetic Act (FD&C Act). Specifically, Mr. Wright offered for sale animals for slaughter as food that contained 0.151 parts per million (ppm) of flunixin in the liver tissue of one animal and 0.512 parts per million (ppm) in the liver of another. 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 (C.F.R.), Section 556.286 (21 C.F.R. 556.286). The presence of flunixin in the edible tissue from these animals 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). Additionally, the letter cited Mr. Wright for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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 letter cited Mr. Wright for administering flunixin meglumine without following the withdrawal times as stated in the approved labeling, and for administering flunixin meglumine to two cows without following the dose as stated on the approved labeling. The extralabel use was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and Mr. Wright’s extralabel use of flunixin meglumine resulted in illegal drug residues, in violation of 21 C.F.R. 530.11(d). Because his use of this drug was not in conformance with its approved labeling, nor his veterinarian's prescribed labeling, and did not comply with 21 C.F.R. 530, Mr. Wright 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).

Name: Edward O’Donnell, General Manager
Date: 10/14/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Direct Reference Warning Letter was issued by the Detroit District Office to Mr. Edward O’Donnell, General Manager, Irish Acres Dairy, LLC, Berne, IN, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, Mr. O’Donnell offered for sale an animal for slaughter as food that was adulterated with 0.578 parts-per-million (ppm) and 0.272 ppm of sulfadimethoxine in the liver and muscle tissues, respectively. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.640(b)(1), (21 C.F.R. 556.640 (b)(1)). The presence of this drug in the 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). Additionally, the letter cited Mr. O’Donnell for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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).

Name: Tony T. Bos, Owner
Date: 10/13/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Tony T. Bos, Owner, Bos Dairy, LLC, Fair Oaks, IN, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, Mr. Bos offered for sale an animal for slaughter as food that was adulterated with 0.755 parts-per-million (ppm) and 0.767 ppm of sulfadimethoxine in the liver and muscle tissues, respectively. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.640(b)(1), (21 C.F.R. 556.640 (b)(1)). The presence of this drug in the 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). Additionally, the letter cited Mr. Bos for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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).

Name: Richard Longway, Co-Owner
Date: 10/05/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Direct Reference Warning Letter was issued by the New England District Office to Mr. Richard Longway, Co-Owner, Longway Farm, Swanton, VT, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. Longway offered for sale animals for slaughter as food that were adulterated. Specifically, one bob veal calf was found to have 17.53 parts per million (ppm) of neomycin in the kidney tissues, and two other bob veal calves were found to have 21.58 ppm and 8.25 ppm neomycin in the kidney tissues. FDA has established a tolerance of 7.2 ppm for neomycin in the kidneys for cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.430 (21 C.F.R. § 556.430). The presence of this drug in the kidneys from these 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)). Additionally, the letter cited Mr. Longway for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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).

Name: Robert L. Rohrer, Co-owner and Partner
Date: 9/24/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Robert L. Rohrer, Co-owner and Partner of Rohrer Dairy Farms, LLC, Washington Boro, PA, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, Mr. Rohrer offered for sale an animal for slaughter as food that was adulterated with penicillin at (b)(4) parts per million (ppm) in the kidney tissue. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). 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. Rohrer for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, Mr. Rohrer was cited for adulterating the new animal drug Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010. His extralabel use of Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and his extralabel use of Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, resulted in an illegal residue, in violation of 21 C.F.R. 530.11(d). Because his use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Rohrer caused the drug to be unsafe under section 512(a) of 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).

Name: Jeffrey A. Trout, Co-Owner
Date: 9/17/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Jeffrey A. Trout, Co-Owner, Trout Brothers Farm, LLC, Loysville, PA, for violation of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. Trout offered for sale animals for slaughter as food that were adulterated. Specifically, he sold two veal calves with 9.65 parts per million (ppm) and 15.56 ppm, respectively, of neomycin residues in the kidney tissues. 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 (C.F.R.), 556.430(b)(1) (21 C.F.R. 556.430(b)(1)). He also sold a dairy cow with flunixin in the liver at 0.308 ppm. FDA has established a tolerance of 0.125 ppm for residues of flunixin in the liver tissues of cattle, as codified in 21 C.F.R. 556.286. The presence of these drugs in edible tissues from these animals in this amount causes the food to be adulterated within the meaning of section 402(a)(2) of the Act, 21 U.S.C. § 342(a)(2). The letter also cited Mr. Trout for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, the letter cited Mr. Trout for adulterating the new animal drug flunixin. His extralabel use of flunixin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and his extralabel use of flunixin resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because his use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, he caused the drug(s) to be unsafe under section 512(a) of 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).

Name: Neil K. McIsaac III, President/Owner
Date: 9/9/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Neil K. McIsaac III, President/Owner, Neil McIsaac & Son, Inc, Petaluma, CA, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. McIsaac offered for sale an animal for slaughter as food that was adulterated with penicillin in the kidney at 0.55 parts per million (ppm). 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, Code of Federal Regulations (C.F.R.), 556.510 (21 C.F.R. 556.510). 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). Mr. McIsaac was cited for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, the letter cited Mr. McIsaac for adulterating the new animal drugs Penicillin G Procaine and Ceftiofur (b)(4). He did not use (b)(4) (Penicillin G Procaine Injectable Suspension U.S.P.) and (b)(4) (Ceftiofur (b)(4)) as directed by their approved labeling. Because his use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, Mr. McIsaac caused the drugs to be unsafe under section 512(a) of 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).

Name: Roy L. Raber, Owner
Date: 9/8/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Roy L. Raber, Owner, Raber View Holstein, Millersburg, OH, for violation of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. Raber offered for sale an animal for slaughter as food that was adulterated with 0.829 parts per million (ppm) of sulfamethoxazole in the muscle and 0.484 ppm of sulfamethoxazole in the liver. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of cattle. The presence of this drug in edible tissue 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). Mr. Raber was cited for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, the letter cited Mr. Raber for adulterating the new animal drug sulfamethoxazole and trimethoprim (800 mg/160 mg per tablet). He administered the human drug sulfamethoxazole and trimethoprim tablets to a bull calf without following the withdrawal period as stated in the approved labeling or any written directions by a licensed veterinarian. His extralabel use of sulfamethoxazole and trimethoprim tablets was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a); and his extralabel use of sulfamethoxazole and trimethoprim tablets resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(c). Because his use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Raber caused the drug to be unsafe under section 512(a) of 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).

Name: Keith A. Reddick, Owner
Date: 8/30/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Keith A. Reddick, Owner, Reddick Dairy, Stoneboro, PA, for violations of the Federal Food, Drug and Cosmetic Act (the Act). Mr. Reddick offered for sale an animal for slaughter as food that was adulterated with flunixin residues of 3.732 parts per million (ppm) in the liver, and 0.5088 ppm in the muscle. Flunixin is not approved for use in calves to be processed for veal. 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii). The letter also cited Mr. Reddick for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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).

Name: Kenneth C. Corscadden
Date: 8/17/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Kenneth C. Corscadden, Corscadden Family Farm, Richville, NY, for violation of the Federal Food, Drug and Cosmetic Act (the Act). Mr. Corscadden offered for sale animals for slaughter as food that were adulterated. Specifically, he sold four bob veal calves and one cow with the following residues:

TAG ID: Slaughter Date Residue  Tolerance Drug
 Calf (b)(4) 09/25/098.26 ppm Liver
3.76 ppm Muscle
13.88 ppm Kidney
 
6 ppm Liver
2 ppm Muscle
12 ppm Kidney
 
Tetracycline
Tetracycline
Tetracycline
 
 Calf (b)(4) 10/16/092.35 ppm Muscle2 ppm MuscleTetracycline
 Calf (b)(4) 10/16/0957.24 ppm Kidney
10.27 ppm Muscle
 
12 ppm Kidney
2 ppm Muscle
 
Tetracycline
Tetracycline
 
 Calf (b)(4) 10/30/096.58 ppm Liver
2.42 ppm Muscle
 
6 ppm Liver
2 ppm Muscle
 
Tetracycline
Tetracycline
 
 Cow (b)(4) 02/09/101.96 ppm Kidney0.05 ppmPenicillin

FDA has established the following tolerances for residues of tetracycline in the tissue of calves: 2 parts per million (ppm) in the muscle; 6 ppm in the liver; and 12 ppm in the kidney as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.720 (21 C.F.R. 556.720), and for residues of penicillin in uncooked edible tissue of cattle at 0.05 ppm as codified in 21 C.F.R. 556.510. The presence of these drugs in edible tissues from these animals 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 letter also cited Mr. Corscadden with holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. Food from animals held under such conditions are adulterated within the meaning of section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4). Mr. Corscadden was also cited for adulterating the following new animal drugs: 1) (b)(4); and, 2) (b)(4). His extralabel use of tetracycline was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and his extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Also, his extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and his extralabel use of this drug resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because his use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Corscadden caused the drugs to be unsafe under section 512(a) of 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).

Name: Daniel Visser, Owner
Date: 7/29/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Direct Reference Warning Letter was issued by the Denver District Office to Mr. Daniel Visser, Owner, Dutch Valley Farms, Clovis, NM, for violations of the Federal Food, Drug and Cosmetic Act (the Act). Mr. Visser offered an animal for sale for slaughter as food that was adulterated with 0.333 parts per million (ppm) Sulfadimethoxine in the liver tissue. FDA has established a tolerance of 0.1 ppm for residues of Sulfadimethoxine in the edible tissue of cattle, as codified in Title 21, Code of Federal Regulations, Section 556.640, (21 C.F.R. 556.640). The presence of this drug in the edible tissues of this animal in this amount causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) of the Apt [21 U.S.C. § 342(a)(2)(C)(ii)]. The letter also cited Mr. Visser for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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)]. Additionally, Mr. Visser adulterated the new animal drug (b)(4) Sulfadimethoxine. Specifically, he treated the cow with nearly double the recommended dose. His extralabel use of (b)(4) Sulfadimethoxine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a), and his extralabel use of (b)(4) Sulfadimethoxine resulted in an illegal drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530. Mr. Visser caused the drug to be unsafe under section 512(a) of the Act, [21 U.S.C. §360(a)], and adulterated within the meaning of section 501(a)(5) of the act, [21 U.S.C. §351(a)(5)]

Name: Brian Hill, Owner
Date: 7/13/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Brian Hill, Owner, Dairy Operation, Maple Park, IL, for violations of the Federal Food, Drug and Cosmetic Act (the Act). Mr. Hill offered for sale an animal for slaughter as food that was adulterated with 2.649 parts per million (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, 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 Act, 21 U.S.C. 342(a)(2)(C)(ii). The letter also cited Mr. Hill for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, Mr. Hill adulterated the new animal drug sulfamethazine boluses for cattle. Label directions for use of sulfamethazine boluses in cattle state "Do not use in female dairy cattle 20 months of age or older." His extralabel use of sulfamethazine boluses was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11 (a), and his extralabel use of sulfamethazine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because his extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Hill caused the drug to be unsafe under Section 512(a) of 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).

Name: Robert L. Beckman, Owner
Date: 7/9/2010
Reason: Animals for Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Robert L. Beckman, Owner, Dairy Firm, Cassadaga, NY, for violations of the Federal Food, Drug and Cosmetic Act (the Act). Mr. Beckman offered an animal for sale for slaughter as food that was adulterated with gentamicin sulfate in the liver, kidney, and muscle tissue. FDA has not established a tolerance for residues of gentamicin in edible tissue of veal calves. 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 Act, 21 U.S.C. § 342(a)(2)(C)(ii). The letter also cited Mr. Beckman for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, Mr. Beckman adulterated the new animal drug (b)(4) (Gentamicin Sulfate (b)(4). He administered gentamicin sulfate to a bob veal calf without following the animal species as stated in the approved labeling. His extralabel use of gentamicin sulfate was not under the supervision of a licensed veterinarian, in violation of 21 CFR 530.11(a) and his extralabel use of gentamicin sulfate resulted in an illegal drug residue in violation of 21 CFR 530.11 (c). Because his use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, Mr. Beckman caused the drug to be unsafe under section 512(a) of 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).

Name: Gary L. Topp, D.V.M., Co-Owner
Date: 7/6/2010
Reason: New Animal Drug/Adulterated/Labeling/Misbranded

A Warning Letter was issued to Mr. Gary L. Topp, D.V.M., Co-Owner, Country Road Veterinary Services LLC, Apple Creek, OH, for causing the new animal drug, sulfamethoxazole, 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 Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. Part 530). Dr. Topp’s prescription for extralabel use of this drug did not meet the requirements of 21 C.F.R. 530.12(c) and (e) which require that any animal drug prescribed and dispensed for extralabel 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) 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; and, (2) The veterinarian's specified withdrawal time for meat which might be derived from the treated animal. Because the drug, sulfamethoxazole was prescribed and used in a manner that did not conform with its approved uses or in compliance with 21 CFR Part 530, Dr. Topp caused the drug to be unsafe under section 512(a) of 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).

Name: Ben Gingg
Date: 7/6/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Warning Letter was issued to Mr. Ben Gingg, Triple G Dairy, Buckeye, AZ, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. Gingg offered for sale an animal for slaughter as food that was adulterated with 0.76 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 uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Section 556.640 (21 C.F.R. 556.640). 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. Gingg for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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). Additionally, Mr. Gingg was cited for adulterating the new animal drug Albon (sulfadimethoxine) boluses by not using Albon (sulfadimethoxine) boluses as directed by the approved label. Sulfadimethoxine is prohibited for extralabel use in lactating dairy cattle by 21 C.F.R. 530.41(a)(9), and his extralabel use of sulfadimethoxine resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because his extralabel use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Gingg caused the drug to be unsafe under section 512(a) of 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).

Name: Francis C. Regan, President
Date: 7/2/2010
Reason: Extralabel Drug Use in Animals/Adulterated

A Warning Letter was issued to Mr. Francis C. Regan, President, Regancrest Holsteins, Inc, Waukon, Iowa for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. Regan adulterated the new animal drugs DiMethox (Sulfadimethoxine 12.5% Solution Oral Form, ANADA 200-030), Agrimycin 100 (Oxytetracycline Hydrochloride Injection, ANADA 200-452), and TyloVed (Tylosin Phosphate 200 mg/mL Injection, NADA 138-955). Mr. Regan administered sulfadimethoxine, oxytetracycline, and tylosin to a lactating dairy cow without following the conditions of use 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). His extralabel use of these drugs were not under the supervision of a license veterinarian, in violation of 21 C.F.R. 530.11 (a). Because his use of these drugs was not in conformance with their approved labeling and did not comply with 21 C.F.R. Part 530, Mr. Regan caused the drugs to be unsafe under section 512(a) of 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).

Name: Keith and Patricia Haldiman
Date: 6/30/2010
Reason: Animal Sale for Slaughter as Food/Adulterated

A Direct Reference Warning Letter was issued by the Minneapolis District Office to Mr. Keith and Mrs. Patricia Haldiman, Dairy Operation, Hilbert, WI, for violations of the Federal Food, Drug, and Cosmetic Act (the Act). Mr. & Mrs. Haldiman offered for sale an animal for slaughter as food that was adulterated with sulfamethazine at 37.280 parts per million (ppm) in liver tissue and 65.57 ppm in muscle tissue. The USDA/FSIS analysis also identified the presence of phenylbutazone in kidney tissue. The FDA has established a tolerance of 0.1 ppm for sulfamethazine in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations, section 556.670 (21 CFR 556.670). However, this tolerance does not apply to sulfamethazine in lactating dairy cattle. There is no acceptable level of sulfamethazine residue in lactating dairy cattle. There is also no acceptable level of phenylbutazone residue in lactating dairy cattle. The presence of these drugs in edible tissues from this animal 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 the Haldimans for holding animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. 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).