FDA WARNING_LETTER - Annasea International Hawaii, LLC - March 05, 2013

An FDA inspection of Annasea International Hawaii LLC's seafood processing facility from February 21 to March 5, 2013, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123) and labeling regulations (21 CFR 101). Consequently, the firm's seafood products, including ready-to-eat scombroid finfish like sashimi and poke, and vacuum packaged tuna loins, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. The "Wasabi Poke" product is also adulterated under Section 402(c) and misbranded under Section 403 of the Act. HACCP deficiencies include failure to conduct adequate hazard analyses for pathogen growth, toxin formation, and undeclared allergens; inadequate critical limits; insufficient monitoring procedures and frequencies; and failure to implement both monitoring and record-keeping systems. Additionally, the firm failed to maintain sanitation control records. Labeling violations for "Wasabi Poke" encompass adulteration due to undeclared FD&C Yellow No. 5, and misbranding for failing to declare major food allergens (soy, wheat, tuna, silversides), provide a complete ingredient list with sub-ingredients, declare artificial colorings, include the manufacturer's name and place of business, and state the net quantity of contents. The inspection also noted double packaging of "Wasabi Poke" that could foster Clostridium botulinum growth. The firm's initial response was inadequate, requiring submission of revised HACCP plans, monitoring records, and labels within 15 working days to avoid further action, including product seizure, injunction, and re-inspection fees.