FDA WARNING_LETTER - Family Fresh Pack, LLC - January 19, 2011

The FDA inspected Family Fresh Pack, LLC's seafood processing facility in Belleville, Wisconsin, from December 2010 to January 2011. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulations (21 CFR Part 110). Consequently, their Lobster Bisque, Shrimp Scampi, and Crab Creole products are deemed adulterated.

Key violations include: 1. **Inadequate HACCP Plans:** The HACCP plan for Lobster Bisque, Shrimp Scampi, and Crab Creole cheese spreads failed to list food safety hazards such as allergens, *Clostridium botulinum*, and food intolerance substances. Products packaged in oxygen-impermeable containers create conditions for *Clostridium botulinum* growth. 2. **Insufficient Critical Limits:** The HACCP plan's critical limit for temperature (b)(4) was inadequate to control pathogens, potentially allowing pathogen growth during storage. Continuous storage at or below 38°F was recommended. 3. **Failure to Implement Record Keeping:** The firm did not maintain monitoring records for critical control points, including sulfite control in frozen shrimp, and temperature charts for seafood coolers, leading to unmonitored product storage. 4. **Inadequate Sanitation Monitoring:** Employees were observed handling filled cheese cups without proper hand washing and sanitizing