FDA WARNING_LETTER - Cannon Farms, LLC - September 10, 2015

On September 2, 4, and 10, 2015, the FDA inspected a dairy operation at 1470 North 750 East, Shelley, Idaho, identifying violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated animal for slaughter. On July 9, 2015, a cow (ear tag (b)(4), back tag (b)(4)) sold by the operation was slaughtered. USDA/FSIS analysis found penicillin at 0.264 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. § 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the new animal drug PenOne Pro (Penicillin G Procaine Injectable, NADA 065-010) was adulterated due to extralabel use. The operation administered PenOne Pro to the aforementioned cow without adhering to the approved withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. § 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. § 530.11(d