FDA WARNING_LETTER - A. C.' S Chinese Restaurant - February 21, 2013

On February 14, 16, 18, and 21, 2013, the FDA inspected A.C. Chinese Restaurant, a seafood processing facility in Kailua Kona, Hawaii, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's shelf-stable, ready-to-eat dried marlin fish jerky was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions.

The firm's HACCP plan for "AC'S/ASIA TRANS FISH JERKY" was deficient in several areas: 1. **Hazard Analysis (21 CFR 123.6(a) and (c)(1))**: The plan failed to list food safety hazards such as histamine formation, pathogen growth and toxin formation (including *Clostridium botulinum* and *Staphylococcus aureus* toxins) from time/temperature abuse and inadequate drying, and allergens. 2. **Critical Control Points (21 CFR 123.6(a) and (c)(2))**: The plan did not list critical control points for thawing vacuum-packaged raw fish (to control histamine and pathogen growth), cooler storage/marinating (for histamine control), and finished product labeling (for allergens). 3.