FDA WARNING_LETTER - Miller, Andrew J. - July 29, 2008

On July 22 and 29, 2008, the FDA investigated Andrew J. Miller's dairy operation in Big Prairie, OH, and found violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on May 7, 2008, was found to have Penicillin residues in its muscle (26.27 ppm), liver (0.86 ppm), and kidney (0.42 ppm) tissues. This significantly exceeds the FDA tolerance of 0.05 ppm for Penicillin in cattle edible tissues (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions leading to adulterated food under section 402(a)(4) of the Act. Specifically, the operation failed to maintain treatment records, lacked a system to control drug administration, did not have an adequate drug inventory system, and fed milk from treated cows to calves intended for slaughter. These deficiencies indicate a high likelihood of medicated animals with harmful drug residues entering the food supply.

The FDA requires prompt corrective action within fifteen working days of receiving the letter. The response must detail steps taken or planned to correct violations and prevent recurrence, including documentation. Failure to comply may result in regulatory actions such as seizure or injunction.