FDA WARNING_LETTER - Roberts Ranch of Oklahoma LLC - April 23, 2012

On April 2, 3, 12, and 23, 2012, the FDA investigated Roberts Ranch of Oklahoma LLC, a swine raising operation. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on or about November 8, 2011, the company sold pigs for slaughter, and USDA/FSIS analysis of one animal's tissues revealed penicillin in kidney and muscle, which is an illegal residue as FDA has no tolerance for penicillin in swine. This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. This was evidenced by a failure to maintain complete treatment records.

Furthermore, the new animal drug penicillin G procaine (NADA (b)(4)) was adulterated under section 501(a)(5) of the FD&C Act. The company used penicillin G procaine extra-label by administering it to a culled sow without following the approved dosage. This extra-label use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. § 53