FDA WARNING_LETTER - L & L CRAB - April 29, 2015

On April 15-17 and 29, 2015, an FDA inspection of L & L Crab's seafood processing facility in New Iberia, Louisiana, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). Consequently, the firm's frozen vacuum-packed crayfish tail meat, fresh crab meat, and frozen vacuum-packed crab meat products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan for Crayfish Tail Meat:** The firm failed to have a HACCP plan for frozen vacuum-packed crayfish tail meat to control hazards like pathogenic survival, bacterial growth, and C. botulinum toxin formation. The submitted plan was inadequate, lacking critical control points for "Bacterial pathogen growth" and incomplete critical limits for "Cook Crayfish." 2. **Inadequate HACCP Plan for Crab Meat:** The HACCP plan for fresh and frozen vacuum-packed crab meat lacked critical control points at the (b)(4) step for controlling pathogenic bacteria growth and toxin formation. Critical limits for several control points were also insufficient, failing to include necessary temperature or time specifications. 3. **Unidentified Hazards:** The HACCP plan for