FDA WARNING_LETTER - Roman J. Bem - March 02, 2011

On February 18, 2011, through March 2, 2011, the FDA inspected Roman J. Bem's dairy farm at 15000 Route 8, Union City, PA. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on October 25, 2010, a dairy cow sold for slaughter was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on October 26, 2010, identified 0.11 ppm Penicillin and Gentamicin residues in the kidney. This exceeds the FDA tolerance of 0.05 ppm for Penicillin in uncooked edible cattle tissues (21 C.F.R. 556.510(a)), and no tolerance is established for Gentamicin in dairy cows. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

Additionally, the investigation found that animals were held under insanitary conditions, specifically due to a failure to maintain treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply. This is adulteration under section 402(a)(4) of the Act, 21 U.S.