FDA WARNING_LETTER - Vlazar Costa Caribe S.A. - April 29, 2022

On August 15, 2022, the FDA issued a Warning Letter to Vlazar Costa Caribe S.A. following a Foreign Remote Regulatory Assessment conducted from April 26-29, 2022. The assessment revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm failed to respond to discussion items identified during the assessment.

The primary violation cited was the firm's HACCP plan (Version 2) for Precooked Dried Sea Cucumber, which did not list drying as a critical control point to manage pathogenic bacteria growth and toxin formation (Staphylococcus aureus), as required by 21 CFR 123.6(a) and (c)(2). This renders their dried sea cucumber products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), meaning they were prepared, packed, or held under conditions that may render them injurious to health.

Vlazar Costa Caribe S.A. must respond in writing within fifteen working days, outlining specific corrective actions, including a revised HACCP plan, five consecutive days of completed monitoring records, and any additional information demonstrating compliance. Failure to respond adequately may result in further FDA action, including refusal of admission of imported products under section 801(a) of the Act, potentially leading to detention without physical examination