FDA WARNING_LETTER - Bernick's Registered Holsteins - August 02, 2012

On October 1, 2012, the FDA issued a Warning Letter to Bernick's Registered Holsteins following an investigation conducted on July 16, 20, and August 2, 2012. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a dairy cow sold for slaughter on March 23, 2012, was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal identified flunixin at 0.435 ppm in liver tissue, exceeding the FDA tolerance of 0.125 ppm, and detected gentamicin in kidney tissue, for which no tolerance is established. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

The investigation also found that the farm held animals under insanitary conditions, lacking an effective system to control drug administration and ensure treatment records, leading to potential harmful drug residues in the food supply, violating section 402(a)(4) of the Act.

Furthermore, the new animal drugs flunixin meglumine and gentamicin sulfate were adulterated due to extralabel use not in accordance with approved labeling or veterinarian instructions. Flunixin meglumine was administered without following the intravenous route, and gentamicin sulfate was administered to an unapproved animal class. Both extralabel uses were not under licensed veterinarian supervision and resulted in illegal drug residues