FDA WARNING_LETTER - U Okada & Co Ltd - January 29, 2010

On January 22, 25-27, and 29, 2010, the FDA inspected U. Okada & Company Ltd.'s seafood processing facility in Honolulu, Hawaii, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110). These violations render the firm's histamine-forming fish (yellowfin, bonito, albacore, mahimahi) adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Significant violations include: 1. **Inadequate HACCP Plan Monitoring:** The HACCP plan for "AHI - YELLOWFIN, BIGEYE, ALBACORE, MARLIN - BLUE, STRIPED, WAHOO (ONO), MAHI" lists an inadequate monitoring procedure at the Storage critical control point (CCP) for histamine formation. Continuous monitoring and recording of storage temperature (e.g., digital time/temperature data logger) with daily visual checks are recommended. 2. **Inappropriate Corrective Actions:** The corrective action plan for the same products at the Receiving CCP to control histamine formation is inappropriate, as it cannot be accomplished with current monitoring procedures. Recommended actions include rejecting lots with temperature deviations or performing histamine testing. At the Storage CCP, the corrective action