FDA WARNING_LETTER - General Tuna Corporation - March 02, 2012

On March 2, 2012, the FDA issued a Warning Letter to General Tuna Corporation regarding serious deviations from seafood HACCP regulations (21 CFR Part 123) for their pouch-packed tuna. The firm's HACCP plan and supporting documentation, provided upon FDA request, revealed that their products are considered adulterated under the U.S. Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1))**: The HACCP plan failed to list *Staphylococcus aureus* (S. aureus) growth and toxin formation as a reasonably likely food safety hazard, particularly in post-precooking operations where competitive organisms are eliminated and extended exposure times without temperature controls exist. 2. **Missing Critical Control Points (21 CFR 123.6(a) and (c)(2))**: The HACCP plan for scombrotoxin (histamine) formation listed only "Fish Receiving" as a CCP, neglecting numerous subsequent processing steps and cumulative exposure times that could lead to histamine formation, especially with extended periods above 21°C. 3. **Inappropriate Corrective Actions (21 CFR 123.7(b))**: * For histamine testing at "Fish Receiving," the plan's re-sampling of lots exceeding critical limits was inappropriate;