Sinu Co., Ltd – FDA Warning Letter, Apr 8, 2019

On July 24, 2019, the FDA issued a Warning Letter to Sinu Co., Ltd. following an April 8, 2019 inspection of their seafood processing facility in Busan, South Korea. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their refrigerated salted shrimp adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include an inadequate HACCP plan for salted shrimp. The plan's critical limits for controlling pathogen growth were insufficient. Specifically, for reduced oxygen packaged refrigerated salted shrimp, the "Keep Refrigerated" label was inadequate for controlling *Clostridium botulinum* growth and toxin formation; freezing with specific labeling or a water phase salt level of 5% or more with refrigeration at 4°C (40°F) or below is required. Additionally, the critical limit for the thawing, cleaning, and salting steps was inadequate, lacking time and temperature controls for unrefrigerated processing.

The firm's corrective action plan was also deemed inappropriate. Corrective actions for critical control points did not adequately address the disposition of affected products or correcting the cause of deviations. For undeclared allergens, the corrective action of "pack in correct package" was insufficient, needing modification of labeling procedures.

Sinu Co., Ltd. must respond within