Shang Jiuan Co., LTD – FDA Warning Letter, May 21, 2019

On August 15, 2019, the FDA issued a Warning Letter to Shang Jiuan Co., Ltd. following a May 20-21, 2019 inspection of their seafood processing facility in Taiwan. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their frozen tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The firm's revised HACCP plan, submitted in response to an FDA 483, was deemed inadequate. Key deficiencies include: 1. **Inadequate Hazard Analysis and Critical Control Points (CCPs):** The HACCP plan for "Frozen fish meat (Flake, block strip, diced, whole round fish and other shapes)" failed to list CCPs for controlling scombrotoxin (histamine) formation and pathogen growth/toxin formation for both ready-to-eat and ready-to-cook tuna. Specifically, it lacked CCPs for refrigerated thawing (where tuna was held for up to (b)(4) hours) and unrefrigerated processing/handling (where tuna was exposed to unrefrigerated conditions for XXXX amount of time). 2. **Inadequate Critical Limits:** The HACCP plan lacked adequate critical limits at the "(b)(4)" CCP to control *Clostridium botulin