As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Promar Seafood S. de R. L.
La Ceiba, Honduras

A food firm in Honduras is on notice from the FDA for serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation

In a March 1, 2023, warning letter, the FDA described a Jan. 31 through Feb. 15, 2023, Foreign Remote Regulatory Assessment (FRRA) of  Promar Seafood S. de R. L. seafood processing facility in La Ceiba, Honduras.

Failure of a processor of fish or fishery products to have and implement a Hazard Analysis and Critical Control Point (HACCP) plan that complies with regulation renders the fish or fishery products adulterated. Accordingly, the firm-cooked, dried, shelf-stable, sea cucumber products are adulterated, in that they have been prepared, packed or held under conditions whereby they may have been rendered injurious to health.

Some of the significant violations are as follows:

• The firm does not have a written HACCP plan that outlines controls for a food safety hazard that is reasonably likely to occur as required. Specifically, they do not have a HACCP plan for their cooked, dried, shelf-stable, sea cucumber products intended for the U.S. market to control the hazard of pathogenic bacteria growth and toxin formation including Staphylococcus aureus.

The firm’s hazard analysis and flow chart indicate a (redacted) step with multiple (redacted) steps and then a (redacted) step that is a critical safety barrier for products distributed without refrigeration. The hazard analysis identifies pathogen hazards, but considers the hazards prevented or controlled through the implementation of pre-requisite programs.

The full warning letter can be viewed here.

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