FDA WARNING_LETTER - Galhano Dairy - October 24, 2011

On October 3, 4, 11, and 24, 2011, the FDA inspected Galhano Dairy in Visalia, California, and found violations of the Federal Food, Drug, and Cosmetic Act. Two cows offered for slaughter as food were adulterated. On August 5, 2011, a cow (back tag (b)(4)) was slaughtered, and kidney tissue analysis by USDA/FSIS revealed 1.22 ppm of penicillin. On August 9, 2011, another cow (ear tag # (b)(4), back tag (b)(4)) was slaughtered, and kidney tissue contained 1.36 ppm of penicillin. The FDA's tolerance for penicillin in uncooked cattle tissue is 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.

The dairy also held animals under insanitary conditions, failing 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 FD&C Act. Furthermore, the new animal drug penicillin G procaine injectable suspension ((b)(4)) was adulterated because it was used extralabelly without veterinary supervision, violating