FDA WARNING_LETTER - MIN JIANG FOOD STORE INC DBA KOI KOI TRADING - April 26, 2019

On August 2, 2019, the FDA issued a Warning Letter to Min Jiang Food Store, Inc., dba Koi Koi Trading, following an inspection on April 23 and 26, 2019, at their Montebello, CA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 117).

The FDA determined that the firm's fresh filleted salmon for raw consumption and refrigerated vacuum-packaged surimi seafood products are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they were prepared, packed, or held under insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan:** The HACCP plan for "Fresh Filleting Non Scrombroid Fish Products – (Raw Consumption)" failed to list a critical control point for controlling parasites in ready-to-eat salmon, despite the hazard analysis indicating parasites are reasonably likely to occur. 2. **Failure to Implement Monitoring Procedures:** The firm did not continuously monitor cooler temperatures at critical control points for pathogen growth and toxin formation, as specified in their HACCP plans. Employees lacked access to the electronic database for temperature monitoring. Additionally, HACCP monitoring activities were only conducted on certain days, despite routine