A seafood processing facility in Massachusetts is on notice from the Food and Drug Administration for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation.

Officials from the FDA inspected the East Bridgewater, MA, a warehouse of D’Andrea Foods Inc. on Feb. 11 and 15, 2019. According to a March 15 warning letter recently made public by the FDA, the facility’s refrigerated, ready-to-eat (rRTE) seafood salads and tuna salads may be injurious to health because they were prepared, packed or held under unsanitary conditions.

The report cited the following significant violation in relation to the seafood HACCP regulation for fish or fishery products:

The firm failed to conduct, or have conducted for them, a hazard analysis for each kind of fish and fishery product that they produce to determine whether there are food safety hazards that are reasonably likely to occur.

Additionally, the firm must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur. However, the firm does not have a HACCP plan for:

1.      rRTE seafood salads to control the food safety hazard of pathogenic bacteria growth and toxin formation; and

2.      rRTE tuna salads to control the food safety hazard of pathogenic bacteria growth and toxin formation and scombrotoxin (histamine) formation.

A March 5 response letter was noted by the FDA regarding Inspectional Observations, however, “your firm’s response is inadequate because you did not provide any information that indicates you have conducted a hazard analysis and implemented an adequate HACCP plan for your rRTE seafood salads and tuna salads.”

The FDA’s 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, the Hazards Guide, “provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products.”

The Hazards Guide states that, “This guidance is intended to assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find information in this guidance that will help them identify hazards that are associated with their products, and help them formulate control strategies. The guidance will help consumers and the public generally to understand commercial seafood safety in terms of hazards and their controls.”

The FDA allows companies 15 working days to respond to warning letters. If companies fail to properly correct violations, legal action can result in the seizure of products and injunctions stopping operations. FDA has not yet posted a closeout letter on the case.