FDA WARNING_LETTER - Rancho Cantera - November 26, 2012

On November 19 and 26, 2012, the FDA investigated Rancho Cantera, LLC, a dairy farm in Kent, Illinois, and found violations of the Federal Food, Drug, and Cosmetic Act. A Holstein dairy cow sold for slaughter on June 18, 2012, was found to have a violative residue of 0.11 ppm of ampicillin in its kidney, exceeding the 0.05 ppm tolerance level for penicillin in cattle, rendering the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions where medicated animals with harmful drug residues could enter the food supply, specifically due to the failure to maintain complete treatment records and a drug inventory system. Furthermore, the new animal drug Polyflex Ampicillin for injectable Suspension, NADA 55-030, was adulterated because it was used extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. Part 530.11(a) and causing the drug to be unsafe and adulterated under Sections 512(a) and 501(a)(5) of the FD&C Act, respectively.

Rancho Cantera's December 5, 2012, response, which described steps to revise treatment protocols, was acknowledged.