FDA WARNING_LETTER - Valley View Pork - May 09, 2013

On April 15, 17, and May 9, 2013, the FDA inspected Valley View Pork LLC's swine operation. The inspection found violations of the Federal Food, Drug, and Cosmetic Act. Specifically, on September 18, 2012, Valley View Pork sold a sow for slaughter that was found to have penicillin residues in its kidney and muscle tissue by USDA/FSIS analysis. FDA has not established a tolerance for penicillin in swine edible tissues (21 CFR 556.510), rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

Additionally, the investigation 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. This constitutes adulteration under 21 U.S.C. 342(a)(4).

Valley View Pork's May 21, 2013, response to the FDA 483 acknowledged updating their SOP with a 21-day penicillin withdrawal period and updating treatment records to include dosage, withdrawal time, and administrator's name. However, the FDA could not verify these corrections as no documentation of the updated treatment records was provided.

Valley View Pork must take prompt action to correct these violations and prevent recurrence. Failure to do so may result