FDA WARNING_LETTER - QL FIGO FOODS SDN BHD - May 22, 2014

The FDA inspected QL Figo Foods SDN BHD's seafood processing facility in Malaysia on May 21-22, 2014, and found violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and labeling/color additive requirements. The firm's products, including fish balls and cuttlefish balls, were deemed adulterated.

Key violations include: 1. **HACCP Plan Deficiencies:** The firm's revised HACCP plans failed to list *Clostridium botulinum* growth and toxin formation as a reasonably likely hazard for IQF, vacuum-sealed products. 2. **Missing Critical Control Points (CCPs):** Plans lacked a CCP for cooling to control post-cook pathogen growth and toxin formation. 3. **Inadequate Monitoring Procedures:** Monitoring at cooking/frying CCPs (2 samples per batch) was insufficient to ensure adequate cooking for all products. Allergen CCP monitoring (label design review) was inadequate to ensure correct labels were applied to corresponding products. 4. **Inappropriate Corrective Actions:** Corrective actions for cooking/frying CCPs ("isolate affected product and reject") were deemed insufficient to prevent adulterated products from entering commerce; destruction, diversion, or recooking were recommended.

Labeling and Color Additive Violations: 1. **Undeclared Allergen:** Dragonfly P