FDA WARNING_LETTER - Pioneer Frozen Foods, Inc - July 20, 2012

On July 11-20, 2012, the FDA inspected Pioneer Frozen Foods, Inc.'s facility in Duncanville, Texas, and found serious violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render their food products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to treat and maintain batters to protect against contamination and growth of microorganisms (21 CFR 110.80(b)(12)):** * Pancake batter was processed without temperature control for up to (b)(4) hours, with temperatures ranging from (b)(4) to (b)(4). This time and temperature abuse could lead to pathogen growth, specifically *S. aureus* and toxin production, which is heat-stable. * Wheeled mixing bowls of batter were moved on wet floors, causing unknown liquid from the wheels to drip onto the lip of the (b)(4) when the bowls were (b)(4) to it. * The firm's August 5, 2012, response stated a food safety specialist would review batter handling, but results were not received. A lip was installed on bowls to prevent dripping, which will be evaluated later.

2. **Failure to clean and sanitize utensils