FDA WARNING_LETTER - Well – Delight Network Corporation

The FDA issued a Warning Letter to Well-Delight Network Corporation following a review of their April 16, 2012, HACCP documentation, identifying significant deviations from Seafood HACCP regulations (21 CFR Part 123). The firm's fresh and frozen tuna products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for fresh and frozen tuna fails to list Clostridium botulinum growth and toxin formation, and undeclared allergens, as reasonably likely food safety hazards. Specific concerns were raised regarding vacuum packaging and carbon monoxide treatment for tuna, which create anaerobic conditions conducive to C. botulinum toxin formation, especially if not maintained below 3.3°C (38°F) with continuous monitoring. The letter recommends including "keep frozen" and "thaw under refrigeration immediately prior to use" on labels for frozen products. For allergens, a critical control point (CCP) for accurate labeling is recommended. 2. **Insufficient Critical Limits (21 CFR 123.6(c)(3)):** The HACCP plan for frozen tuna lacks adequate critical limits at the "Receiving" CCP to control scombrotox