FDA WARNING_LETTER - Hulsbosch Dairy Farm - September 21, 2012

On November 16, 2012, the FDA issued a Warning Letter to Hulsbosch Dairy Farm following an investigation conducted on August 29-30 and September 21, 2012. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a bob veal calf sold for slaughter on May 9, 2012, was found to have adulterated tissues. USDA/FSIS analysis revealed ampicillin at 0.38 ppm in the kidney, exceeding the 0.01 ppm tolerance (21 C.F.R. 556.40), and flunixin at 0.173 ppm in the liver, for which no tolerance is established for veal. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also held animals under insanitary conditions, likely leading to drug residues in the food supply, specifically due to a failure to maintain complete treatment records, violating section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drugs Ampicillin Trihydrate and Flunixin Meglumine were adulterated under section 501(a)(5) of the FD&C Act. The investigation revealed extralabel use of ampicillin without observing the withdrawal period and not