Public Health Service Food and Drug Administration
Detroit District 300 River Place Suite 5900 Detroit, Ml 48207 Telephone: 313-393-8100 FAX: 313-393-8139
January 22, 2013
Mr. David M. Grant
Manchester Veal LLC
600 Strauss Provimi Rd
North Manchester, Indiana 46962
On October 9-10, and December 17, 2012, the U.S. Food and Drug Administration (FDA) conducted an investigation of your veal calf farm operation located at 9942 N 200 W, North Manchester, IN. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 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. 360(b). 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 June 4, 2012 you sold a veal calf identified with ear tag number (b)(4) and retain tag number (b)(4) for slaughter as food. On or about June 4, 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 ampicillin at a level of 1.02 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.01 ppm for residues of ampicillin in the uncooked edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.40 (21 C.F.R. 556.40). The presence of the drugs in the edible tissues from this animal in these amounts causes the food to be adulterated under 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 complete treatment records. 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 your overall operation and the food you distribute are 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 LCDR Kelli L. Wilkinson, 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 Wilkinson at (313) 393-8120 or by email at email@example.com.
Glenn T. Bass
Detroit District Office
Cc: Mr. Terry W. Harrell, Farm Manager
Manchester Veal LLC dba Calf Start (FEI: 3009924992)