FDA WARNING_LETTER - Northeast Seafood Products, Inc. - October 19, 2021

The FDA inspected a seafood processing facility in Denver, Colorado, from September to October 2021, following a multistate Salmonella Thompson (S. Thompson) outbreak linked to their products, which infected 116 people across 14 states. The firm recalled affected seafood in October 2021. FDA laboratory analyses confirmed the outbreak strain of S. Thompson in 13 of 132 environmental swabs from the facility, including areas near food processing. Whole genome sequencing matched these isolates to both the 2021 and a 2020 outbreak.

The inspection revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) & Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Violations included inadequate monitoring of cleaning and sanitizing, cross-contamination risks, condensation dripping onto food contact surfaces, and poorly maintained equipment. Sanitation control records were found to be inaccurate and not completed at the time of observation. The facility also had structural deficiencies like cracked floors and damaged walls, and standing water in drains.

The FDA determined the firm's seafood was adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. While the firm initiated a recall, ceased operations, and hired a consultant for corrective actions, including revising their environmental