FDA WARNING_LETTER - Brenner Brothers & Sons - February 17, 2012

On February 1, 13, and 17, 2012, the FDA inspected Brenner Brothers & Sons' dairy operation in Hopkins, Michigan, and found violations of the Federal Food, Drug, and Cosmetic Act.

The FDA found that a cow sold for slaughter on June 9, 2011, with ear tag (b)(4) and back tag (b)(4), was adulterated. USDA/FSIS analysis of liver tissue from this animal, slaughtered on June 10, 2011, revealed sulfadimethoxine at 0.119 ppm, exceeding the 0.1 ppm tolerance (21 C.F.R. 556.640). This violates section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the operation held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act, 21 U.S.C. § 342(a)(4).

The firm also adulterated the new animal drug Di-Methox Injection ANADA 200-0