FDA WARNING_LETTER - Manchester Veal, LLC - December 17, 2012

The FDA conducted an investigation of Manchester Veal LLC's veal calf farm in North Manchester, Indiana, on October 9-10 and December 17, 2012. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale an adulterated veal calf for slaughter on June 4, 2012. Tissue samples from this animal showed ampicillin residues of 1.02 parts per million (ppm) in the kidney, significantly exceeding the FDA tolerance of 0.01 ppm (21 CFR 556.40). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation found that animals were held under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under section 402(a)(4) of the FD&C Act. A key deficiency contributing to this was the failure to maintain complete treatment records. Manchester Veal LLC is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. The firm is required to respond in writing within fifteen working days, detailing corrective actions taken or planned, including documentation. Failure to comply may result in regulatory actions such as seizure or injunction.