FDA WARNING_LETTER - Southeast Asian Food Product - January 14, 2011

The FDA inspected Southeast Asian Food Product's seafood processing facility from December 2010 to January 2011, identifying serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, the firm's refrigerated, vacuum-packaged, ready-to-eat fish cakes and fish balls are deemed adulterated under 21 U.S.C. § 342(a)(4). The firm's revised HACCP plan was found inadequate, and FDA recommended hiring a qualified consultant.

Key violations include failure to conduct a proper hazard analysis and list critical control points for fish cakes (Clostridium botulinum toxin formation) and fish balls (pathogen growth during cooling). The HACCP plans also contained inadequate critical limits for fish cakes (cooling temperature/time) and fish balls (cold storage temperature). Monitoring procedures and frequencies were insufficient, and the firm failed to implement monitoring and record cooler temperatures between September and December 2010. Additionally, the firm did not take appropriate corrective actions when critical limits were exceeded, and the corrective actions listed in their HACCP plans were deemed inappropriate for controlling hazards like pathogen growth and undeclared allergens. The HACCP plan was also incomplete regarding storage and distribution information. The firm must respond within fifteen working days with specific corrective actions and supporting documentation, or face potential product seizure or operational injunction.