FDA WARNING_LETTER - Pacific Exchange Distributors, Llc - September 28, 2010

On December 28, 2010, the FDA issued a Warning Letter to Pacific Exchange Distributors, LLC, following an inspection from September 23-28, 2010, at their Gardena, CA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110).

The FDA determined that the firm's California and Futomaki sushi rolls containing imitation crab meat, and Onigiri rice balls containing tuna, salmon, and mackerel, were adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations included: 1. **Lack of HACCP Plans:** The firm failed to conduct a hazard analysis and implement written HACCP plans for sushi rolls with imitation crab meat and rice balls with tuna, salmon, and mackerel, to control hazards like pathogen growth (e.g., *Listeria monocytogenes*, *Bacillus cereus*). Additionally, HACCP plans for products containing allergens lacked control strategies for allergen identification on packaging. (21 CFR 123.6(a), (b)) 2. **Insufficient Sanitation Monitoring:** The firm did not sufficiently monitor sanitation conditions