FDA WARNING_LETTER - Scariano Brothers, LLC - January 18, 2012

On January 17-18, 2012, the FDA inspected Scariano Brothers, LLC in Hammond, Louisiana, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123) and Current Good Manufacturing Practice (21 CFR 110). The inspection resulted in a FORM FDA 483, Inspectional Observations, issued on January 18, 2012.

The company's PBC Pasteurized Jumbo Lump, Blue Pasteurized Crab Lump, PBC Pasteurized Claw Meat, Blue Pasteurized Crab Claw Meat, and Pasteurized Special Crab Meat products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 USC 342(a)(4)) because they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. Failure to conduct a hazard analysis for each fish and fishery product processed (21 CFR 123.6(a)). 2. Failure to have a written HACCP plan for reasonably likely food safety hazards (21 CFR 123.6(b)). 3. Failure to have an employee complete required HACCP training or be HACCP certified (21 CFR 123.10).

The FDA may take further action, including product seizure and injunctions,