FDA WARNING_LETTER - Pacheco & Fagundes Dairy - July 10, 2012

On June 13, 14, 28, and July 10, 2012, the FDA investigated Pacheco & Fagundes Dairy. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on May 3, 2012, the dairy sold a cow for human consumption that was found to have desfuroylceftiofur in its kidney tissue at 9.19 ppm, exceeding the tolerance of 0.4 ppm. This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the Act.

Furthermore, the dairy engaged in extralabel use of several new animal drugs—ceftiofur hydrochloride, oxytetracycline hydrochloride injection, cephapirin sodium, and penicillin G procaine injectable suspension—without following approved labeling directions or the supervision of a licensed veterinarian, violating 21 C.F.R. Part 530. This caused the drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act.

Pacheco & Fagundes Dairy must