FDA WARNING_LETTER - Modesto Junior College - August 02, 2012

On July 31 and August 2, 2012, the FDA inspected Modesto Junior College's swine unit, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. A sow sold for slaughter on February 3, 2012, was found to have penicillin residues in muscle and kidney tissues, for which FDA has no established tolerance, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including 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 college adulterated new animal drugs, specifically penicillin G benzathine and penicillin G procaine, oxytetracycline injection, and ceftiofur sterile suspension, by using them extralabelly without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). The extralabel use of penicillin G benzathine and penicillin G procaine also resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). These actions caused the drugs to be unsafe and adulterated under 21 U.S.C