FDA WARNING_LETTER - Fuller Family Dairy, LLC - October 04, 2011

On September 29 and October 4, 2011, the FDA investigated Fuller Family Dairy, LLC, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale bob veal calves for slaughter that were adulterated, containing unsafe levels of new animal drugs. Specifically, three bob veal calves sold on December 27, 2010, and February 7 and 14, 2011, and slaughtered on December 28, 2010, and February 8 and 15, 2011, showed violative penicillin residues in muscle and kidney tissues, exceeding the 0.05 ppm tolerance or having no acceptable level for bob veal calves.

The investigation also found insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. Furthermore, the dairy engaged in extralabel drug use of (b)(4) (penicillin-dihydrostreptomycin in oil) and (b)(4) (penicillin G procaine) without following approved labeling or veterinary supervision. This included administering (b)(4) in cow's colostrum to bob veal calves, violating the labeled prohibition on feeding colostrum for (b)(4) hours post-calving, and resulting in illegal drug residues. Additionally, (b)(4) (penicillin G procaine) was administered to