FDA WARNING_LETTER - Mariscos Bahia, Inc. - October 21, 2022

The FDA and California Department of Public Health inspected Mariscos Bahia Inc. from October 6-21, 2022, following a multistate *Salmonella Litchfield* outbreak linked to their fresh, raw salmon, affecting 39 people in 4 states. Environmental samples from the facility tested positive for *Salmonella Litchfield* (matching the outbreak strain), *Salmonella Mbandaka*, and *Salmonella Oranienburg*.

The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) & Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). These violations render the firm's fresh salmon and other seafood adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Specific violations include: 1. **CGMP Violation (21 CFR 117.80(c)(2)):** Failure to minimize microbial growth/contamination. *Salmonella* was found on 18 environmental swabs from various surfaces, including wooden pallets, a trash can, a pallet jack, floor drains, processing equipment, and a washdown hose. The firm's root-cause analysis was deemed insufficient for not considering all potential contamination sources. 2. **Seafood HAC