Pyrenees Dairy – FDA Warning Letter, Jan 3, 2008

On March 14, 2008, the FDA issued a Warning Letter to Pyrenees Dairy, co-owned by Mr. and Mrs. Frank Arburua, following an inspection on December 18, 2007, and January 3, 2008. The inspection revealed that the dairy offered adulterated animals for slaughter and caused a new animal drug, Pen-Aqueous® penicillin G procaine, to become unsafe and adulterated.

Specifically, three cows sold for slaughter on March 6, May 3, and July 23, 2007, had penicillin residues exceeding the 0.05 ppm tolerance (e.g., 0.44 ppm in kidney, 0.24 ppm in liver). This violates sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, rendering the food adulterated.

The dairy lacked an adequate system to ensure appropriate drug withdrawal times, failing to maintain animal treatment records. Furthermore, the extralabel use of penicillin G procaine violated 21 CFR Part 530, as it was administered without following approved dosage levels or licensed veterinarian supervision, and resulted in illegal drug residues. This caused the drug to be unsafe under section 512(a) and adulterated under section 501(a)(5)