FDA WARNING_LETTER - Jernigan Dairy - February 06, 2014

On February 3, 4, and 6, 2014, the FDA inspected Jernigan Dairy and found violations of the Federal Food, Drug, and Cosmetic Act. Two cows sold for slaughter were adulterated, containing penicillin residues exceeding the 0.05 ppm tolerance (0.341 ppm and 0.151 ppm in kidney tissue), violating 21 U.S.C. § 342(a)(2)(C)(ii).

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, violating 21 U.S.C. § 342(a)(4).

Furthermore, Jernigan Dairy adulterated new animal drugs, specifically penicillin G procaine injectable suspension and flunixin meglumine injectable solution, by using them extralabelly without following approved labeling or veterinarian prescriptions. The extralabel use of penicillin G procaine was not under veterinary supervision and resulted in illegal drug residues, violating 21 C.F.R. 530.11(a) and (d). The extralabel use of flunixin meglumine injectable solution was also not under veterinary supervision, violating 21 C.F.R. 530.11(a). These actions caused the drugs to be unsafe and adulterated under 2