Officials from the FDA’s West Division Office of Human and Animal Food inspected the Caruthersville, MO, location of Mann’s Fish Market on May 18-19. According to the June 20 warning letter recently made public by the FDA, the facility’s paddlefish and paddlefish roe may be injurious to health as they were prepared, packed, or held under insanitary conditions.
The report cited several significant violations in relation to HAACP plan for fish or fishery products:
- The firm failed to conduct, or have conducted, 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;
- The firm failed to have and implement a written HACCP plan for their paddlefish and paddlefish roe products, to control food safety hazards which may include pathogen growth and environmental chemicals/pesticides;
- The firm’s plastic containers holding the paddlefish and paddlefish roe products could allow for a reduced oxygen environment conducive to Clostridium botulinum growth and toxin formation as a result of time and temperature abuse; and
- Specifically,”As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States”, the firm is responsible for ensuring that their overall operation and the products they distribute are in compliance with the law.
The FDA inspector referenced the 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance, the Hazards Guide, “which 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 seizure of products and injunctions stopping operations. FDA has not yet posted a closeout letter on the case.
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