FDA WARNING_LETTER - Rohrer Dairy Farms Llc - June 09, 2010

On June 9, 2010, the FDA inspected Rohrer Dairy Farms, LLC, finding violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on February 9, 2010, was found to have penicillin at 0.45 ppm in kidney tissue, exceeding the 0.05 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the firm illegally used Penicillin G Procaine Injectable Suspension U.S.P., NADA 065-010, in an extralabel manner without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a), and resulting in an illegal residue, violating 21 C.F.R. 530.11(d). This rendered the drug unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5).

The FDA