FDA WARNING_LETTER - Corner View Dairies - March 17, 2010

The FDA conducted an investigation of Corner View Dairies, owned by Mr. Raymond L. Martin, on March 3, 12, and 17, 2010, at its Lyons, New York location. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale a bob veal calf for slaughter that was adulterated, as tissue samples showed penicillin at 1.83 ppm in the kidney, exceeding FDA's zero tolerance for veal calves, violating 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found that animals were held under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which adulterates food under 21 U.S.C. 342(a)(4). A key deficiency noted was the failure to maintain treatment records. Furthermore, the firm adulterated the new animal drug penicillin G procaine (Penicillin Injection) by not using it as directed by its approved labeling. This extralabel use involved administering the drug to a veal calf, a class of animal not specified in the labeling, and without a licensed veterinarian's order, violating 21 C.F.R. 530.11(a). This extralabel use also resulted in an illegal residue, violating 21 C.F.R. 530.11(c), rendering the drug unsafe and adulterated under 21 U.S.C. 351(a)(5).

Corner View Dairies is required to take prompt corrective actions, establish preventative procedures, and respond to the FDA within fifteen working days, detailing steps taken or planned. Failure to comply may lead to further regulatory actions like seizure or injunction.