AB Seafood Trading Inc – FDA Warning Letter, May 24, 2019

The FDA inspected AB Seafood Trading, Inc. on May 15, 17, and 24, 2019, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). Consequently, the firm's refrigerated and raw, ready-to-eat seafood products, including tuna, salmon, and vacuum-packaged yellowtail, are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the firm's failure to conduct a proper hazard analysis for each product, specifically omitting parasites for raw, ready-to-eat seafood, as required by 21 CFR 123.6(a) and (c)(1). The HACCP plan also lacked adequate critical limits to control hazards like Clostridium botulinum toxin formation for vacuum-packed yellowtail, violating 21 CFR 123.6(c)(3). Furthermore, the firm failed to implement listed monitoring procedures and frequencies, such as not reviewing continuous temperature monitoring data, leading to critical limit excursions without corrective action, contrary to 21 CFR 123.6(b) and (c)(4). Lastly, sanitation conditions and practices, including food contact surfaces, cross-contamination prevention, and pest exclusion, were not monitored with sufficient frequency to comply with 21 CFR Part 117 and 21 CFR 123.11(b). The FDA requires a written response within fifteen working days detailing corrective actions and supporting documentation, warning of potential product seizure or injunction if violations persist.