Inspections, Compliance, Enforcement, and Criminal Investigations
Twin Oaks Dairy, LLC 9/8/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
RETURN RECEIPT REQUESTED
September 6, 2012
Mr. Mark A. Potter, Co-owner
Twin Oaks Dairy, LLC
8660 Findley Road
Mercersburg, PA 17236
Dear Mr. Potter:
On May 24, 2012 & June 4, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy farm operation located at 8660 Findley Road, Mercersburg, PA. 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 FD&C 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 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. Further, under section 402(a)(4) of the FD&C 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 January 2, 2012, you sold a dairy cow, identified with back tag (b)((4), for slaughter as food. On or about January 3, 2012, (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 Dihydrostreptomycin in the kidney at 38.23 parts per million (ppm). FDA has established a tolerance of 2.0 ppm for residues of Dihydrostreptomycin in the edible tissues of cattle, as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.200 (21 C.F.R. § 556.200). The presence of this drug in edible tissue(s) 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).
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 an adequate inventory system for determining the quantities of drugs used to medicate your cows and calves. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C 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 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.
Your written response should be sent to Robin M. Rivers, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Ms. Rivers at (215) 717-3076 or E-mail at firstname.lastname@example.org.
Kirk D. Sooter
FDA 483 dated June 4, 2012