Inspections, Compliance, Enforcement, and Criminal Investigations
Valmont Dairy LLC 7/12/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
July 12, 2011
WARNING LETTER NYK 2011-26
VIA UNITED PARCEL SERVICE
Aaron L. Widrick, Partner
Valmont Dairy, LLC
6946 State Route 26
Lowville, New York 13367-4835
Dear Mr. Widrick:
On February 8 through 10, 2011, investigators from the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 6946 State Route 26, Lowville, New York. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 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.
We found that you offered for sale an animal for slaughter as food which 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 5, 2010, you sold a bob veal calf, identified with backtag (b)(4) for slaughter as food. On or about August 6, 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 sulfamethoxazole in the liver at 0.483 parts per million (ppm) and in the muscle at 0.669 ppm. 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 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 you hold animals under conditions which 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 you adulterated the human drugs su1famethoxazole and trirnethoprim that were contained in the product labeled as "Tribrissen 960 mg." Specifically, our investigation revealed you did not use the product labeled as "Tribrissen 960 mg" containing the human drugs sulfamethoxazole and trimethoprim as directed by your prescribing veterinarian. 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 you administered the human drugs sulfamethoxazole and trimethoprim that were contained in the product labeled as "Tribrissen 960 mg" to your bob veal calf without following the withhold period as stated in the veterinarian's prescription. Your extralabel use of the human drugs sulfamethoxazole and trimethoprim that were contained in the product labeled as "Tribrissen 960 mg" 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 product labeled as "Tribrissen 960mg" was not in conformance with your veterinarian's prescription 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 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 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, Ext. 3168.
Ronald M. Pace
New York District