FDA WARNING_LETTER - Neil McIsaac & Son, Inc. - July 19, 2010

On July 7 and 19, 2010, the FDA investigated Neil McIsaac & Son, Inc.'s dairy operation in Petaluma, California, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on April 20, 2010, was found to have penicillin in its kidney at 0.55 ppm, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the company adulterated new animal drugs Penicillin G Procaine and Ceftiofur by using them extralabelly without proper veterinary supervision, violating 21 C.F.R. 530.11(a). Specifically, Penicillin G Procaine was administered to two cows without observing the veterinarian's prescribed withdrawal period, resulting in illegal drug residues (21 C.F.R. 530.11(d)). Ceftiofur was administered to another cow without following the approved labeling's frequency of