Dixon Fisheries Inc FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory Violations

This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the seafood HACCP regulation (21 CFR 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.

Potential Health Risks

We inspected your seafood processing facility, located at 1807 N. Main Street, East Peoria, IL on August 8, 2017 through August 15, 2017. During the inspection we found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123. In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of Part 123, renders the fish or fishery products adulterated within the meaning of section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your cheesy crab spread and scallop and shrimp macaroni salad produ

Regulatory Context

Your significant violations are as follows:

1.    You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(l). A food safety hazard is defined in 21 CFR 123.3(f) as "any biological, chemical, or physical property that may cause a food to be unsafe for human consumption." However, your firm's HACCP plans for cheesy crab spread and scallop and shrimp macaroni salad do not list the food safety hazards of Clostridium botulinum growth and toxin formation and undeclared food allergens.

2.    You must have a HACCP plan that, at a minimum, lists monitoring procedures and their frequency for each critical control point, to comply with 21 CFR 123.6(c)(4). However, your firm's HACCP plans for cheesy crab spread and scallop and shrimp macaroni salad do not list monitoring frequencies at the thaw, preparation, and holding critical control points to control the hazard of bacterial growth and survival for the crab flakes, scallop and shrimp. FDA recommends that refrigeration temperatures be monitored and recorded continuously with a visual check of the monitoring device at least once per day.