In a March 1, 2023, warning letter, the FDA described a Jan. 31 thru Feb. 15, 2023, Foreign Distant Regulatory Overview (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 contain and put into effect a Hazard Prognosis and Excessive Management Point (HACCP) design that complies with regulation renders the fish or fishery products adulterated. Accordingly, the company-cooked, dried, shelf-stable, sea cucumber products are adulterated, in that they’ve been ready, packed or held below prerequisites whereby they’d per chance had been rendered detestable to health.
Some of the quite a bit of violations are as follows:
• The company does not contain a written HACCP design that outlines controls for a food security hazard that’s reasonably at possibility of happen as required. Namely, they wouldn’t contain a HACCP design for their cooked, dried, shelf-stable, sea cucumber products supposed for the U.S. market to manipulate the hazard of pathogenic micro organism boost and toxin formation including Staphylococcus aureus.
The company’s hazard prognosis and stride chart whisper a step with quite a lot of steps after which a step that will per chance well also very successfully be a serious security barrier for products distributed with out refrigeration. The hazard prognosis identifies pathogen hazards, but considers the hazards averted or managed thru the implementation of pre-requisite programs.