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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Gerald Thompson Farm 13-Nov-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

New York District
300 Pearl Street, Suite 100
Buffalo, NY 14202


 


November 13, 2006

WARNING LETTER NYK 2007-02

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Gerald C. Thompson, Owner
Gerald Thompson Farm
17416 County Rt. 11
LaFargeville, New York 13656

Dear Mr. Thompson:

An investigation of your dairy farm operation located 17416 County Rt. 11, LaFargeville, New York, conducted by representatives of the U.S. Food and Drug Administration (FDA) on May 31 and June 2, 2006, confirmed that you offered an animal for sale for slaughter as food that, was adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. §342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. §342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the new animal drug, Quartermaster penicillin-dihydrostreptomycin in oil, to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. §351(a)(5)] and unsafe under section 512 [21 U.S.C. §360b] of the Act. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

On, or about, February 28, 2006, you consigned a dairy cow for slaughter as food to cattle trucker [redacted] identified the cow with back tag [redacted] and sale tag [redacted]. This animal was subsequently delivered to [redacted] and slaughtered there on, or about, February 28, 2006. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected revealed 0.17 ppm penicillin in kidney tissue of the cow identified with back tag [redacted] and sale tag [redacted]. A tolerance of 0.05 ppm has been established for residues of penicillin in uncooked edible tissues of cattle (Title 21, Code of Federal Regulations, Part 556.510 (21 C.F.R. 556.510). The presence of this drug, in this amount, in edible tissues from this animal causes the food to be adulterated within the meaning of section 402(a)(2)(C)(ii) [21 USC §342(a)(2)(C)(ii)] of the Act.

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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues.

For example, you failed to maintain written treatment records which document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, and withdrawal times for milk and beef. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) [21 USC §342(a)(4)] of the Act.

In addition, you adulterated Quartermaster penicillin-dihydrostreptomycin in oil within the meaning of section 501(a)(5) [21 USC §351(a)(5)] of the Act when you failed to use the drug in conformance with its approved labeling. "Extralabel use", i.e ., the actual or intended use of a drug in an animal in a manner that is not in accordance with the approved labeling, is only permitted if the use is by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship. The extralabel use of approved veterinary or human drugs must comply with Sections 512(a)(4) [21 USC §360b(a)(4)] and 512(a)(5) [21 USC §360b(a)(5)] of the Act and 21 C.F.R. Part 530. Our investigation found that your extralabel use of Quartermaster penicillin-dihydrostreptomycin in oil failed to comply with these requirements.

For example, you administered Quartermaster penicillin-dihydrostreptomycin in oil without following the withdrawal time of 60 days, from the time of infusion, before shipping the cow for slaughter for human food. Specifically, you administered Quartermaster penicillin-dihydrostreptomycin iri oil to the cow sometime in February 2006, and consigned it for slaughter on or about February 28, 2006, contrary to approved label instructions. You did so without the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a).

Furthermore, your extralabel use resulted in an illegal drug residue, in violation of 21 C.F.R. 530.11(d). Because your extralabel use of this drug was not in compliance with 21 C.F.R. Part 530, the drug was unsafe under section 512(a) [21 USC §360b(a)] of the Act, and your use caused it to be adulterated within the meaning of section 501(a)(5) [21 USC §351(a)(5)] of the Act.

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 above violations and to establish procedures whereby such 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, 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. Clark, 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 Patricia A. Clark at 716-551-4461, extension 3168.

Sincerely yours,

/S/


Otto D . Vitillo
District Director
New York District