Public Health Service
Food and Drug Administration
Cincinnati District Office
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761
August 22, 2014
Clarence H. Hoover, Owner
Hoover Family Farm
1094 W. Hinton Road
Scottsville, KY 42164
Dear Mr. Hoover:
On June 16, 2014 through June 19, 2014, the U.S. Food and Drug Administration (FDA) conducted an investigation of your farm located at 1094 W. Hinton Road, Scottsville, Kentucky. 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.
Specifically, our investigation revealed that on or about April 1, 2014, you sold a calf, identified with ear tag(b)(4)for slaughter as food. On or about April 3, 2014, (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 0.072 parts per million (ppm) of penicillin in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the kidney tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510(a) (21C.F.R. 556.510(a)). 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 FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).
The above is not intended to be an all-inclusive list of violations. As a dealer 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.
We received your letter in which you promise to correct the violations by 1) Asking about the health of animals that you purchase or if any drugs have been given 2) Getting bills from the stockyard and 3) Filling out drug forms. We cannot evaluate the effectiveness of your corrective action because you have not supplied us with any records showing implementation of your actions. In your response to this letter, you should include copies of any documentation that you have to substantiate that you are in fact asking about the medication status of the animal and examples of the records you are maintaining from the stockyards or if you have medicated any animals.
Your written response should be sent to Stephen J. Rabe, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Rabe at (513)679-2700, ext. 2163, or email@example.com.