Lao Thai Nam Corporation – FDA Warning Letter, Apr 4, 2014

On March 24, 2014, through April 4, 2014, the FDA inspected Lao Thai Nam Corporation in Dallas, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The firm's "Number One Sompa Salted Fish" product was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan Critical Limits (21 CFR 123.6(c)(3)):** * The HACCP plan for Salted Fish had an inadequate critical limit at the (b)(4) critical control point (CCP) for pathogen growth and toxin formation, specifically for *Bacillus cereus* and *Staphylococcus aureus*. The revised draft HACCP plan also lacked a (b)(4) CCP and secondary barriers for *Clostridium botulinum* toxin production. A CCP for labeling to ensure frozen product is kept frozen was also suggested. * The critical limit for "Cold Storage of raw ingredients" CCP ("Storage Temperatures to be kept (b)(4)°F") was insufficient to control *Clostridium botulinum* in uneviscerated, unprocessed, vacuum-packed, frozen fish ingredients. The revised