FDA WARNING_LETTER - Chean Industries Dominicana S.R.L. - March 01, 2023

The FDA issued a warning letter to Chean Industries Dominicana S.R.L., following an inspection of its seafood processing facility in Santiago, Dominican Republic, conducted from February 28 to March 1, 2023. The inspection revealed significant violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations under Title 21, Code of Federal Regulations (21 CFR Part 123). Key issues included the absence of a HACCP plan for dried sea cucumbers to address hazards such as environmental chemicals and pathogenic bacterial growth, specifically Staphylococcus aureus. Additionally, the firm"s critical limits for controlling bacterial growth and toxin formation were inadequate, as they failed to ensure a water activity level of 0.85 or below, necessary to inhibit toxin formation.

Furthermore, the facility lacked proper sanitation control records, failing to document essential monitoring and corrections related to food safety and hygiene practices. The FDA requires Chean Industries to submit a corrective action plan within 15 working days, including a revised HACCP plan and evidence of compliance through monitoring records. Failure to address these issues may result in further regulatory actions, such as detention without physical examination of imported products. The company is urged to ensure ongoing compliance with the Federal Food, Drug, and Cosmetic Act and applicable regulations.