FDA WARNING_LETTER - Oak Grove Pork Inc - February 27, 2013

On February 11 and 27, 2013, the FDA investigated Oak Grove Pork Farm Inc. and found violations of the Federal Food, Drug and Cosmetic Act. The firm sold an adulterated sow for slaughter on September 24, 2012, which was shipped to (b)(4). USDA/FSIS analysis on September 25, 2012, revealed violative penicillin residues in the kidney, exceeding the zero tolerance level (21 CFR Part 556.510). This constitutes adulteration under Section 402(a)(2)(C)(ii) of the FD&C Act and a violation of Section 301(a) for selling adulterated food in interstate commerce.

The investigation also found 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, violating Section 402(a)(4). Furthermore, the firm adulterated the new animal drug Norocillin (penicillin G procaine) NADA 065-010 by administering it to a sow without following approved labeling dosage. This extralabel use was not under a licensed veterinarian's supervision (21 CFR 530.11(a)) and resulted in an illegal drug residue (21 CFR 530.11(c)), rendering the drug unsafe (