FDA WARNING_LETTER - The Famous Lartigue Seafood - October 25, 2021

The FDA inspected a seafood processing facility at 100 Plantation Pointe, Fairhope, AL, on October 19, 20, and 25, 2021, identifying serious violations of the Seafood Hazard Regulations (21 CFR Part 123). The facility's seafood products are deemed adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Lack of HACCP Plan:** The facility does not have a written HACCP plan for fresh sushi-grade salmon to control parasite and environmental hazards, violating 21 CFR 123.6(a) and (b). The company's response stated a plan would be devised after HACCP certification, but no enrollment documentation or timeline was provided. 2. **Missing Sanitation Control Records:** The facility lacks sanitation control records for key areas like food contact surface cleanliness, cross-contamination prevention, handwashing facilities, food protection, toxic compound control, and employee health, violating 21 CFR 123.11(c). While the company claimed to use daily/monthly logs, no supporting documentation was provided. 3. **Lack of HACCP-Trained Individual:** The facility does not have an individual trained in HACCP principles for fish and fishery product processing, as required by 21 CFR 123.