FDA WARNING_LETTER - Meiko Food Company Inc. - August 19, 2010

On August 10-19, 2010, the FDA inspected Meiko Food Company Inc.'s seafood processing facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110). As a result, their fish paste and ready-to-eat pasteurized fish ball products are deemed adulterated.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for Raw Fish Paste to control *Clostridium botulinum*, metal, and allergens. 2. **Inadequate Sanitation Monitoring:** Failure to sufficiently monitor pest exclusion (flies on fish paste, slug on mixer), cleanliness of food contact surfaces (uncleaned machines, stained tubs), proper labeling/storage/use of toxic chemicals (bleach in lawn sprayer), and safety of water (no backflow device on hose). 3. **Insufficient Sanitation Records:** Failure to maintain sanitation monitoring records for water safety and pest exclusion for fish paste and fish balls. 4. **Inaccurate Sanitation Records:** Records for food contact surfaces, toxic compounds, and employee practices were inadequate, showing "pass" when observations indicated otherwise (e.g., "pass" for employee health when employees hadn't arrived). 5. **Missing Critical Limits:** HACCP plan for ready-