FDA WARNING_LETTER - Mutual Trading Company Inc - May 25, 2010

On May 17-25, 2010, the FDA inspected Mutual Trading Company, Inc.'s seafood processing/importer/distribution facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulation (21 CFR Parts 110 & 123). These violations render their seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for pasteurized refrigerated imitation crab meat in oxygen-reduced packaging (21 CFR 123.6(a) and (b)). 2. **Inadequate Monitoring Procedures:** The HACCP plan for Mackerel with (b4) lists a CCP for (b4) and another for (b4) for monitoring refrigerator temperature using a digital probe thermometer with visual checks (b4) times a day, which is insufficient for continuous temperature maintenance (21 CFR 123.6(c)(4)). 3. **Failure to Implement Record Keeping and Calibration:** The firm did not monitor as frequently as stated in their HACCP plan for Mackerel with (b4) and failed to calibrate continuous recording chart thermometers and digital probe thermometers as required by their HACCP plans (