FDA WARNING_LETTER - Jorge Dairy - June 29, 2012

On June 25 and 29, 2012, the FDA inspected Jorge Dairy in Atwater, California, and found violations of the Federal Food, Drug, and Cosmetic Act. One cow consigned for slaughter on January 9, 2012, was found to have penicillin at 2.29 ppm in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The dairy also failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, Jorge Dairy used sterile penicillin G procaine injectable suspension extralabelly, not following approved labeling for dosage, injection site amount, and withdrawal period. This extralabel use was not under a licensed veterinarian's supervision, violating 21 C.F.R. 530.11(a), making the drug unsafe and adulterated under 21 U.S.C. § 351(a)(5).

Jorge Dairy must take prompt action to correct these violations and prevent recurrence. A written response detailing corrective actions and timelines is required within fifteen working days to the FDA San Francisco District office. Failure to comply may result in