| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
August 18, 2011
WARNING LETTER NYK 2011-31
VIA UNITED PARCEL SERVICE
L. Sheldon Davis, Owner
Davis Farm
66-2 Davis Road
Berkshire, New York 13736
Dear Mr. Davis:
On June 27 and 29, 2011, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm located at 66-2 Davis Road, Berkshire, New York. 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 the 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 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 October 4, 2010, you sold a bob veal calf, identified with sale tag (b)(4) for slaughter as food. On or about October 5, 2010, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety an Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 19.134 parts per million (ppm) of sulfamethazine in the liver tissue and 27.784 ppm of sulfamethazine in the muscle. FDA has not established a tolerance for residues of sulfamethazine in the edible tissue of bob veal calves. 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 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 treatment records, and identify 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 drug (b)(4) Specifically, our investigation revealed that you did not use this drug as directed by its approved labeling. Use of this drug in this manner is an extralabel use. Title 21, Code of Federal Regulations C.F.R.), Section 530.3(a), 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 veterinary within the context of a valid veterinarian/client/patient relationship.
Our investigation found that you administered sulfamethazine to a bob veal calf without following the animal class as stated in the approved labeling. Your extralabel use of sulfamethazine was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a) and your extralabel use of sulfamethazine resulted in an illegal drug 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.
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 Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
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