FDA WARNING_LETTER - Crestview Calves, Inc. - November 05, 2009

On November 3 and 5, 2009, the FDA inspected a calf raising operation in Hazelton, Idaho, and found violations of the Federal Food, Drug, and Cosmetic Act. The operation offered for sale animals for slaughter as food that were adulterated.

Specifically, two calves sold for slaughter on August 14 and August 26, 2009, respectively, were found to have gentamicin sulfate in their kidney tissues. The FDA has not established a tolerance for gentamicin sulfate residues in cattle, rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act.

Additionally, the investigation revealed insanitary conditions, including a failure to maintain treatment records for the medicated animals, which could lead to harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the Act.

The new animal drug gentamicin sulfate was also found to be adulterated. The drug was used extralabelly, not as directed by the veterinarian's prescription or approved labeling, violating 21 C.F.R. 530.3(a). This extralabel use resulted in illegal drug residues, violating 21 C.F.R. 530.11(c), and caused the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5)