Is Neilsen Seafood Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

The FDA identified regulatory violations in Neilsen Seafood's operations or product claims.

Potential Health Risks

You must maintain sanitation control records that, at a minimum, document monitoring and corrections set out in 21 CFR 123.11(b), to comply with 21 CFR 123.11(c). However, your firm did not maintain sanitation monitoring records for the maintenance of hand washing, hand sanitizing, and toilet facilities; protection of food, food packaging material, and food contact surfaces from adulteration with lubricants, fuel, pesticides, cleaning compounds, sanitizing agents, condensate, and other chemical, physical, and biological contaminants; proper labeling, storage, and use of toxic compounds; and control of employee health conditions that could result in the microbiological contamination of food, food packaging materials, and food contact surfaces. Specifically, your “(b)(4)” records do not cont

Regulatory Context

You must conduct, or have conducted for you, hazard analysis for each kind of fish or fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur, and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur to comply with 21 CFR 123.6(a) and (b). However, your firm does not have a HACCP plan for refrigerated, ready-to-eat crab meat to control the food safety hazards of environmental chemical contaminants, pathogenic bacterial growth due to temperature abuse, pathogenic bacterial survival through cooking or pasteurizing, allergens, and metal inclusion.