Shung Kee Food Co., Ltd. – FDA Warning Letter, Nov 15, 2019

The FDA issued a Warning Letter to Shung Kee Food Co., Ltd. following an inspection from October to November 2019, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's fish ball and fish cake products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(4)):** The revised HACCP plan for boiled fish balls, fried fish cakes, and fried fish balls in hermetically sealed packaging lists an inadequate monitoring procedure for the "Post Cooking Process (Cooling and packing)" critical control point (CCP). Internal temperature probes were not consistently placed in representative locations, leading to observed temperatures 30°F higher than recorded. The monitoring frequency ("at least every (b)(4)") is also insufficient to ensure critical limits are met. 2. **Failure to Implement Record Keeping System (21 CFR 123.6(b) and (c)(7)):** The firm did not record monitoring observations for the "Post-Cooking Processing Cooling" CCP for several days in January 2019, despite manufacturing products. 3. **Failure to Document Corrective Actions (21 CFR 1