FDA WARNING_LETTER - American Sea Food Company, Inc. - February 18, 2010

On February 1-18, 2010, the FDA inspected American Sea Food Company, Inc.'s facility, identifying serious deviations from seafood HACCP Regulations (21 CFR Part 123). These deviations render the firm's scombroid-forming fishes adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Despite the firm's April 2010 responses, including an updated HACCP plan, the scombroid-forming fish remain adulterated. Key violations include:

1. **Inadequate HACCP Plan Critical Limits:** The "Fresh and Frozen Tuna" HACCP plan lacks sufficient critical limits at the Receiving CCP to control histamine formation in scombroid species received directly from harvest vessels. The current critical limit ("All lots received are accompanied by harvest vessel records") is inadequate. The FDA recommends sensory examination of at least 118 fish per lot and internal temperature measurement of a minimum of 12 fish. For fish from other vendors, transportation records must show temperatures at or below 40°F or adequate icing. The HACCP plan must also cover all scombroid species, including Mahi-Mahi.

2. **Failure to Implement Monitoring Procedures:** The firm did not follow its HACCP plan's monitoring procedures for scombroid fish receipt, specifically regarding internal temperature checks and supplier certification verification. Examples cited include lack of documented product temperature