Pork Champ, LLC 2/9/12
| || |
Department of Health and Human Services
|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
February 9, 2012
WARNING LETTER CIN-12-276436-11
Dave E. Heisler and William Ringler, Owners
Pork Champ, LLC
1136 Coldicott Hill Road
Lucasville, OH 45648-9595
Dear Mr. Heisler and Mr. Ringler:
On November 29 through December 1, 2011 the U.S. Food and Drug Administration (FDA) conducted an investigation of your hog farm located at 1136 Coldicott Hill Road, Lucasville, OH. 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 FDA’s web page at www.fda.gov
We found that you offered for sale an animal for slaughter 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.
Specifically, our investigation revealed that on or about August 15, 2011 you sold a sow with a yellow ear tag number 4300 for slaughter as food through (b)(4) Also on or about August 15, 2011 (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected on August 15, 2011 from this sow with ear tag number 4300, identified the presence of 1.5 parts per million (ppm) penicillin in the kidney of this animal. The FDA has established a tolerance of ZERO for residue associated with use of penicillin in the edible tissue of swine as codified in Title 21, Code of Federal Regulations (C.F.R.), Part 556.510(b) (21 C.F.R. Part 556.510(b)). The presence of this drug in the edible tissue of this sow 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).
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 an update for 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 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.
Paul J. Teitell