FDA WARNING_LETTER - L.A. Star Seafood Company, Inc. - May 15, 2013

On June 14, 2013, the FDA issued a Warning Letter to L.A. Star Seafood Company, Inc. following an inspection from May 7-15, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The firm's refrigerated ready-to-eat fishery products, including cold smoked and cured/pickled items, were deemed adulterated. Key violations included: 1. **Inadequate HACCP Plans:** Failure to identify histamine formation and pathogenic bacteria growth as food safety hazards for products like (b)(4). The proposed August 15, 2013, update timeframe was deemed unacceptable. 2. **Insufficient Critical Limits:** Critical limits for (b)(4) in the (b)(4) HACCP plan were inadequate to control *Clostridium botulinum*, lacking scientific support or finished product testing. 3. **Missing HACCP Plans:** No HACCP plans existed for products such as pickled herring, vacuum-packed cold smoked herring, vacuum-packed cold smoked escolar, and cold smoked sprat. 4. **Failure to Implement HACCP:** The firm did not follow monitoring, recordkeeping, or verification procedures outlined in its (b)(4) HACCP plan, including