Inspections, Compliance, Enforcement, and Criminal Investigations
S & W Farms 19-Jun-07
Department of Health and Human Services
Public Health Service
Cincinnati District Office
June 19, 2007
VIA FEDERAL EXPRESS
Stanley H. Wilson, Owner
S & W Farms
200 Crews Road
Cave City, KY 42127-8908
Dear Mr. Wilson:
An investigation of your dairy and beef operations located in Cave City, Kentucky, was conducted by a representative of the U.S. Food and Drug Administration (FDA) on March 26 and 27, 2007. This investigation confirmed that you offered animals for sale for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) [21 U.S.C. 342(a)(2)(C)(ii)] and 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug, and Cosmetic Act (the Act). The inspection also revealed that you caused the drug penicillin to become adulterated within the meaning of section 501(a)(5) [21 U.S.C. 351(a)(5)] and unsafe under section 512 of the Act [21 U.S.C. 360b]. You can find the Act and its associated regulations on the Internet through links on the FDA web page at www.fda.gov.
On or about September 26, 2006, you consigned a dairy cow, identified with back tag 9382, for slaughter at [redacted]. On or about September 27, 2006, this animal was slaughtered at [redacted]. The United States Department of Agriculture Food Safety and Inspection Service's (USDA/FSIS's) analysis of tissue samples collected from that animal identified the presence of 0.10 ppm penicillin in kidney tissue and 0.09 ppm penicillin in the liver tissue.
On or about November 28, 2006, you consigned a dairy cow, identified with back tag 8976, for slaughter at [redacted]. On or about November 30, 2006, this animal was slaughtered at [redacted]. The USDA/FSIS's analysis of tissue samples collected from that animal identified the presence of 0.19 ppm penicillin in kidney tissue.
A tolerance of 0.05 ppm has been established for the residues of penicillin in edible tissues of cattle as codified in Title 21, Code of Federal Regulations, Part 556.510(a). The presence of this drug in edible tissues from these animals 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. You lack an adequate system to ensure that animals medicated by you have been withheld from slaughter for appropriate periods of time to permit depletion of potentially hazardous residues of drugs from edible tissues. For example, your firm's animal treatment records do not include the identity of the animal, the drug administered, the dosage given, the route of administration, the individual who administered the drug, and the appropriate withdrawal times; you lack an adequate drug inventory system for determining the quantities of drugs used to medicate your animals; and you are not adequately identifying and segregating treated animals. 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)].
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 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 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 Gina M. Brackett, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Ms. Brackett at (513) 679-2700, ext. 167.
Carol A. Heppe
cc: R. Kevin Vance, DVM
Hartland Animal Hospital
6425 S. Jackson Highway
Horse Cave, KY 42742