FDA WARNING_LETTER - Rayong Fish Sauce Industry Co., Ltd. - January 24, 2008

On January 24, 2008, the FDA inspected LAX-C Inc., a U.S. importer of fish and fishery products, and found them importing fish sauce from Rayong Fish Sauce Industry Co., Ltd. The FDA collected Rayong Fish Sauce Industry Co., Ltd.'s HACCP plan for anchovy-based fish sauce, which revealed serious deviations from 21 CFR Part 123, rendering their product adulterated under 21 USC § 342(a)(4).

Key violations include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCP) (21 CFR 123.6(a) and (c)(2)):** The HACCP plan failed to include critical control points for histamine formation and pathogen growth at: * **Receiving raw anchovies:** No controls for primary or secondary processors to prevent histamine formation and pathogen growth during transit. * **Storage of raw anchovies:** No temperature controls (4.4°C/40°F or below) to prevent histamine and pathogen growth before salting. * **Evisceration or Destruction of Preformed Toxin (Clostridium botulinum):** No evisceration step for fish 5 inches or longer, or a boiling step for smaller un-eviscerated fish to destroy preformed toxin. * **Brining of Fermented