Inspections, Compliance, Enforcement, and Criminal Investigations
Clearview Farms 6/10/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-30977
Telephone: (513) 679-2700
FAX: (513) 679-2761
June 10, 2010
WARNING LETTER CIN-10-105505-13
Via United Parcel Service
Albert J. Miller, Owner
7792 Frease Road
Fredericksburg, Ohio 44627
Dear Mr. Miller:
On January 11 and 13, 2010, the U.S. Food and Drug Administration (FDA) conducted an investigation of your farm, located at 7792 Frease Road, Fredericksburg, Ohio. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the Act) that we found during our investigation of your operation. You can find the 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 an animal for sale for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the 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 Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the 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 19, 2009, you sold a bob veal calf, identified with tag (b)(4), for slaughter as food. On or about August 20, 2009, (b)(4), slaughtered this animal. The United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analyses of tissue samples collected from this animal identified the presence of neomycin in the kidney at 7.34 parts per million (ppm). FDA has established a tolerance for residues of neomycin in the uncooked edible tissue of cattle at 7.2 ppm, as codified in Title 21, Code of Federal Regulations, Section 556.430 (21 C.F.R. 556.430). 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).
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 complete treatment records. 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).
Our investigation also found that you caused the drug, Draxxin (Tulathromycin) Injectable Solution, NADA 141-244, to be unsafe within the meaning of section 512(a)(4) of the Act, 21 U.S.C. 360b(a)(4), because the drug was used in a manner that did not conform with its approved uses or the regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530.
The extralabel use of approved animal or human drugs in animals is allowed under the Act only if the extralabel use complies with sections 512(a)(4) and 512(a)(5) of the 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 that you administered Draxxin (Tulathromycin) Injectable Solution, NADA 141-244 to a bull calf intended to be slaughtered as veal without following the product's approved labeling. Your extralabel use of Draxxin (Tulathromycin) Injectable Solution, NADA 141-244 was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 CFR Part 530, you 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).
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 Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, OR 45237. If you have any questions about this letter, please contact Compliance Officer Parmon at 513-679-2700 Ext. 162.
Teresa C. Thompson