FDA WARNING_LETTER - A Simoes Family Dairy - March 11, 2010

On March 9 and 11, 2010, the FDA inspected A. Simoes Family Dairy in Ontario, California, and found violations of the Federal Food, Drug, and Cosmetic Act. On October 21, 2009, the dairy sold a culled cow for slaughter, which, upon USDA/FSIS analysis, contained 0.15 ppm of penicillin residue in the kidney. This exceeds the FDA tolerance of 0.05 ppm for penicillin in uncooked edible cattle tissues (21 C.F.R. 556.510).

The investigation determined the dairy's use of Pro-Pen-G Injection (Penicillin G Procaine Injectable Suspension, NADA 065-505) led to the illegal residue. The firm used the drug extralabel, meaning not as directed by its approved labeling, which is only permissible under specific conditions (21 C.F.R. Part 530). The dairy administered Pro-Pen-G Injection without following approved indications and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This extralabel use resulted in illegal drug residues, violating 21 C.F.R. 530.11(d). Consequently, the drug was deemed unsafe (section 512(a) of the Act,