FDA WARNING_LETTER - Malda, Jeff - March 05, 2010

On March 2 and 5, 2010, the FDA inspected Jeffrey T. Maida's dairy operation in Cato, New York, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary issue involved the sale of a bob veal calf for slaughter that was found to be adulterated. Tissue samples from the calf revealed florfenicol residues (4.40 ppm in liver, 0.73 ppm in muscle), for which no FDA tolerance exists in veal calves, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Furthermore, the firm held animals under inadequate conditions, including a failure to maintain treatment records and segregate treated animals, making food from such animals adulterated under 21 U.S.C. 342(a)(4). The new animal drug florfenicol itself was also deemed adulterated due to its misuse. Specifically, the firm engaged in extralabel use of florfenicol by administering it to a veal calf, a class of animal not specified in the approved labeling, and without the lawful order of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use also resulted in illegal drug residues, a violation of 21 C.F.R. 530.11(c), causing the drug to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5). The FDA requires prompt corrective action and the establishment of procedures to prevent recurrence. A written response detailing these steps is due within fifteen working days, with potential regulatory actions like seizure or injunction for non-compliance.