FDA WARNING_LETTER - Empresas Barsan, Inc. - February 05, 2014

The FDA inspected Empresas Barsan Inc.'s seafood, turnovers, and corn sticks manufacturing facility in Cataño, PR, from January 17 to February 5, 2014. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (cGMP) regulation (21 CFR Part 110). Consequently, the firm's products, including tacos dough and shells, pizza flavored turnovers, seafood tacos, and corn sticks, are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations include the firm's failure to conduct a proper hazard analysis and implement a compliant HACCP plan for seafood products, specifically omitting pathogen growth, toxin formation (e.g., Clostridium botulinum, Staphylococcus aureus), and undeclared allergens. Additionally, cGMP violations were noted, such as inadequate measures to exclude pests (cockroaches observed) from processing areas and failure to maintain facilities in good repair, evidenced by misplaced ceiling tiles, gaps, holes, and detached wall panels where pests were seen. The firm's written response to the FDA-483 was found inadequate, lacking a revised HACCP plan and comprehensive corrections. Empresas Barsan Inc. must respond within 15 working days, outlining specific corrective actions, providing a revised HACCP plan, and submitting at least five days of monitoring records. Failure to comply may result in product seizure, injunction, and re-inspection fees. The letter emphasizes the firm's responsibility for overall compliance with FDA regulations.