FDA WARNING_LETTER - Vistar Corporation - October 21, 2010

On December 22, 2010, the FDA issued a Warning Letter to Vistar Corporation following an inspection from October 18-21, 2010, which revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). These violations render their frozen cooked ready-to-eat Snow Crab, canned pasteurized crabmeat, and frozen cooked lobster adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate HACCP Plans (21 CFR 123.6(c)(3))**: The HACCP plan for frozen cooked lobster lacked critical limits for cook cycle length, steam temperature, and lobster size. The "Crab Product" HACCP plan's critical limit of "Product NTE 40°F at time of receipt" was insufficient to control pathogen growth during transit. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4))**: The cooked lobster HACCP plan lacked monitoring procedures for cooling cycle length, thermometer type, monitoring method, and frequency. It also failed to include monitoring for sulfiting agent declaration on cartons and labeling. 3. **Inadequate Sanitation Monitoring (21 CFR 12