FDA WARNING_LETTER - S W Seafood, Inc. - December 12, 2011

On December 5-12, 2011, the FDA inspected S W Seafood, Inc.'s facility in Brooklyn, NY, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 C.F.R. Part 123). These violations render the firm's live aquacultured Barramundi, Striped Bass, Tilapia, and live wild caught Buffalo Fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for its live aquacultured Barramundi, Striped Bass, Tilapia, and live wild caught Buffalo Fish to control food safety hazards like aquaculture drugs and/or environmental chemicals, violating 21 C.F.R. 123.6(a) and (b). 2. **Inadequate Sanitation Records:** The firm did not maintain sanitation monitoring and correction records for critical areas such as water safety, food contact surface cleanliness, cross-contamination prevention, handwashing facilities, protection from adulteration, toxic chemical control, employee health, and pest exclusion, violating 21 C.F.R. 123.11(c). 3. **Lack of HACCP Training:** No one