FDA WARNING_LETTER - Western United Fish Company, Inc. - March 12, 2008

The FDA inspected the seafood processing facility at 9411 8th Avenue South Seattle, Washington, on March 11 and 12, 2008, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110). Consequently, scombroid species products, including Yellowfin tuna, Bigeye tuna, and Mahi-Mahi, were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to preparation, packing, or holding under insanitary conditions. Specific violations included the firm's HACCP plan for scombroid species lacking adequate monitoring procedures for histamine control at the refrigerated storage Critical Control Point (CCP), as required by 21 CFR 123.6(c)(4). Visual temperature checks were found insufficient, necessitating continuous temperature monitoring. Additionally, corrective action plans for "Receiving" and "Storage" CCPs were deemed inappropriate under 21 CFR 123.7(b), with the "Receiving" action being unimplementable and recommendations for additional actions like product destruction or diversion for "Storage." The firm must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, or explaining delays. Failure to promptly correct these violations could lead to further FDA action, including product seizure or injunctions against operation. The firm is responsible for ensuring full compliance with all applicable regulations.