FDA WARNING_LETTER - Alex Jackson and Wayne Jackson - December 20, 2013

On December 16 & 20, 2013, the FDA inspected Alex and Wayne Jackson's dairy operation in Union, Maine. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

A bob veal calf sold for slaughter on February 4, 2013, was found to have flunixin in its kidney tissue, for which FDA has no established tolerance in preruminating calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the FD&C Act. Deficiencies included failure to maintain treatment records, failure to segregate treated animals, and lack of an adequate drug inventory system.

Furthermore, several new animal drugs, including Flunixin, Furosemide Injection 5%, Florfenicol, Ceftiofur crystalline free acid, Oxytetracycline, and Penicillin G Procaine, were adulterated. These drugs were used extralabelly without veterinary supervision, violating 21 C.F.R. Part 530. Specific instances included administering Flunixin without following animal class labeling, Furosemide Injection 5% and Oxytetracycline to lactating dairy