FDA WARNING_LETTER - Beckman, Robert L. - May 28, 2010

On May 19, 20, and 28, 2010, the FDA inspected Robert L. Beckman's dairy firm in Cassadaga, New York, and found violations of the Federal Food, Drug, and Cosmetic Act.

The firm offered an adulterated bob veal calf for slaughter on October 6, 2009, which was slaughtered on October 9, 2009. USDA/FSIS analysis found gentamicin sulfate in the liver, kidney, and muscle tissue, for which FDA has no established tolerance in veal calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the firm held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically by failing to maintain complete treatment records. This constitutes adulteration under section 402(a)(4) of the Act.

The firm also adulterated the new animal drug Gentamicin Sulfate by using it extralabelly without following approved labeling for animal species. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a), and resulted in an illegal drug residue, violating 21 CFR 530.11(c). This non-conformance caused the drug to be unsafe under section 512(a) and