| Public Health Service Food and Drug Administration |
Detroit District |
Department of Health and Human ServicesWARNING LETTER
2011-DET-02
October 14, 2010
VIA UPS
Edward O'Donnell, General Manager
Irish Acres, LLC
693 East State Road 218
Berne, Indiana 46711
Dear Mr. O'Donnell:
The U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 693 East State Road 218, Berne, Indiana on August 6, 11, 19, and 20, 2010. 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 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 April 29, 2010, you sold a cow, identified with Ear Tag (b)(4) back tag# (b)(4) for slaughter as food. On or about April 30, 2010, (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 0.578 parts-per-million (ppm) and 0.272 ppm of sulfadimethoxine in the liver and muscle tissues, respectively. FDA has established a tolerance of 0.1 ppm for residues of sulfadimethoxine in the uncooked edible tissue of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), 556.640(b)(1), (21 C.F.R. 556.640 (b)(1)). The presence of this drug in the edible tissues from this animal in these amounts 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).
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 Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
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