FDA WARNING_LETTER - Hong's Merchandising Group, Inc. - August 02, 2010

The FDA inspected Hong's Merchandising Group, Inc.'s seafood processing facility in Brooklyn, NY, on July 30 and August 2, 2010, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). As a result, the firm's refrigerated, aquacultured, vacuum packed yellowtail products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. The primary violation identified was the firm's failure to conduct a hazard analysis for each fish product and to implement a written HACCP plan to control reasonably likely food safety hazards, specifically toxin formation including histamine and Clostridium botulinum, as required by 21 CFR 123.6(a) and (b). The FDA requires a written response within fifteen working days, detailing specific corrective actions and including supporting documentation like HACCP and verification records. Failure to promptly correct these violations could lead to further regulatory actions, including product seizure or an injunction preventing the firm's operation. The company is responsible for ensuring full compliance with all applicable regulations to prevent future violations.