FDA WARNING_LETTER - Promar Seafood S. de R.L. - January 12, 2022

On March 1, 2022, the FDA issued a Warning Letter to Promar Seafood S. de R.L. in La Ceiba, Honduras, following a Foreign Remote Regulatory Assessment conducted from January 5-12, 2022. The assessment, necessitated by COVID-19 travel restrictions, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123).

The primary violation identified was the absence of a written HACCP plan for their cooked, dried, shelf-stable sea cucumber products intended for the U.S. market. This plan is required to control the hazard of pathogenic bacteria growth and toxin formation, specifically *Staphylococcus aureus*. The firm's hazard analysis and flowchart indicated processing steps but relied on prerequisite programs to control pathogen hazards, which is insufficient.

Failure to have and implement a compliant HACCP plan renders the seafood products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act, meaning they may have been rendered injurious to health.

Promar Seafood S. de R.L. was directed to respond in writing within fifteen working days, outlining specific corrective actions. The response must include documentation such as a revised HACCP plan, five consecutive days of completed monitoring records demonstrating plan implementation, and any additional information assuring future compliance. Failure to respond adequately may result in further FDA action, including refusal of admission