FDA WARNING_LETTER - Five Star Dairy #2 - December 21, 2012

On December 18 and 21, 2012, the FDA investigated Five Star Dairy #2, located at 14452 Avenue 152, Tipton, California. The investigation revealed several violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on August 21, 2012, Five Star Dairy #2 sold a cow for slaughter that was found to have penicillin at 0.18 ppm in kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This caused the food to be 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. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, Five Star Dairy #2 adulterated the new animal drug sterile penicillin G procaine injectable suspension by using it extralabelly without following approved labeling for dosage, dosage amount per injection site, and withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal