FDA WARNING_LETTER - Advance Pierre Foods - March 11, 2011

On March 8-11, 2011, the FDA inspected a food manufacturing firm in Easley, SC, following a Reportable Food Registry (RFR) notification that their Pierre PB Jamwich peanut butter and strawberry jam products tested positive for *Listeria monocytogenes* (*L. monocytogenes*).

During the inspection, environmental swabs confirmed the presence of *L. monocytogenes* in the facility, specifically in the peanut butter and jelly sandwich processing room. This included standing water under a peanut butter heating kettle and on the floor near a handwashing sink. Previous inspections in May 2010 also found *L. monocytogenes* in the same processing room. Pulsed-field gel electrophoresis (PFGE) analysis showed that *L. monocytogenes* strains from the finished product and environmental samples from both inspections were indistinguishable, indicating a persistent strain and inadequate sanitation.

The FDA also observed serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110), rendering the food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Violations included: 1. **Failure to maintain buildings and fixtures in repair (21 CFR 110.35(a)):** Leaking sinks and equipment (parts washing sink, peanut butter heating kettle, sherbet pasteurization tank) caused standing water in