FDA WARNING_LETTER - jin's seafood enterprise inc., - April 06, 2011

On August 1, 2011, the FDA issued a Warning Letter to Jin's Seafood Enterprise Inc., dba Choi's Fish Market, following an inspection from March 24 to April 6, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their fresh, refrigerated seafood products, including Tuna and Mahi Mahi, adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to conduct a hazard analysis and implement written HACCP plans for refrigerated Mahi Mahi and other scombrotoxin-producing species (for histamine control), refrigerated Salmon (for pathogen growth and parasites), and refrigerated Tuna (for pathogen growth, parasites, and histamine formation). 2. **Missing Critical Limits:** The HACCP plan for refrigerated Mahi Mahi and other scombrotoxin-producing species lacked critical limits for histamine formation. 3. **Failure to Implement Record Keeping:** The firm did not record monitoring observations for histamine formation at the "Receiving" and "Finished product Storage" critical control points for "Ahi processed for cooking," ceasing documentation as of November 2, 2010. 4. **Inappropriate Corrective Actions:** Corrective action plans for Tuna