Inspections, Compliance, Enforcement, and Criminal Investigations
Kidron Auction Inc. 12/30/08
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
FAX: (513) 679-2771
December 30, 2008
Via Federal Express
John E. Sprunger, President
Kidron Auction, Inc. Via Federal Express
4885 Kidron Road
Kidron, Ohio 44636
Dear Mr. Sprunger:
On August 7 and 11, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your auction facility located in Kidron, 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 operations. You can find the Act and its associated regulations on the Internet through links on the FDA 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 February 14, 2008, a calf was consigned for sale at your auction, identified with back tag number (b)(4), and sold to (b)4). This calf was transported (b)(4) to where it was slaughtered on or about February 15, 2008.
United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of 99.30 parts per million (ppm) neomycin in the kidney of this animal. A tolerance of 7.2 ppm has been established for residues of neomycin in the kidney tissue of cattle, as codified in Title 21, Code of Federal Regulations, 556.430(21 CFR 556.430). However, this tolerance does not apply to use of Neo Med 325 in veal calves, and there is no acceptable level of residue associated with use of Neo Med 325 in veal calves.
In addition, USDA/FSIS analysis of tissue samples collected from this animal identified the presence of .22 ppm sulfamethoxazole in the liver and .27 ppm sulfamethoxazole in the muscle of this animal. USDA/FSIS analysis of tissue samples collected from this animal also identified the presence of .075 ppm flunixin in the liver and .021 ppm flunixin in the muscle of this animal. FDA has not established a tolerance for sulfamethoxazole or flunixin residues in the edible tissues of veal calves. The presence of these drugs in edible tissues 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 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. 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). Specifically, you lack a system to ensure that animals you buy and then sell for slaughter as food have not been medicated or, if they have been medicated, to allow them to be withheld from slaughter for an appropriate period of time to deplete potentially hazardous residues of drugs from edible tissues.
The above is not intended to be an all-inclusive list of violations. As a distributor of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute are 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 injunction. To avoid future residue violations you should take precautions such as:
1. Implementing a system to determine whether animals you receive for auction have been medicated, with what drug(s), and the date the withdrawal period (if any) terminates; and
2. Obtaining signed statements from the source of the animal(s), if you are told the animal is not medicated.
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, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Parmon at (513) 679-2700, ext. 162 or by mail at the address in the letterhead.
Teresa C. Thompson
Cc: Dr. Isabel Arrington
U.S. Department of Agriculture/Food Safety and Inspection Service
1299 Farnam Street