Neilsen Seafood – FDA Warning Letter, Nov 7, 2017

On December 19, 2017, the FDA issued a Warning Letter to Timothy Neilsen, Owner of Timothy Neilsen Seafood, following an inspection from November 2-7, 2017. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated, ready-to-eat crab meat adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Lack of HACCP Plan:** The firm failed to conduct a hazard analysis and implement a written HACCP plan for refrigerated, ready-to-eat crab meat to control hazards such as environmental chemical contaminants, pathogenic bacterial growth due to temperature abuse, pathogenic bacterial survival through cooking/pasteurizing, allergens, and metal inclusion (21 CFR 123.6(a) and (b)). 2. **Inadequate Sanitation Control Records:** The firm did not maintain sanitation monitoring records for hand washing/sanitizing/toilet facilities, protection from adulteration by chemicals/contaminants, proper labeling/storage/use of toxic compounds, and control of employee health conditions (21 CFR 123.11(c)).

The FDA advises Neilsen Seafood to refer to the Fish and Fishery Products Hazards and Controls Guidance for appropriate controls. Failure to promptly