Dandong Shenghai Foodstuff Co. Ltd. – FDA Warning Letter, May 17, 2019

On August 15, 2019, the FDA issued a Warning Letter to Dandong Shenghai Foodstuff Co., Ltd. following an inspection on May 16-17, 2019, which revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's frozen, cooked short neck clams were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA found the firm's June 4, 2019, response and revised HACCP plan inadequate. Key violations include: 1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Frozen short neck clams" lacked a critical control point for container integrity to prevent recontamination of pathogenic bacteria during cooling. 2. **Insufficient Monitoring Procedures (21 CFR 123.6(c)(4)):** * For natural toxins, the monitoring frequency of "(b)(4)" was deemed inappropriate; FDA recommends visually checking incoming tags of every container. * For pathogenic bacteria control during cooking, the plan's monitoring of cooking tunnel water temperature using a "(b)(4)" and visual check of belt frequency "(b)(4)" were inadequate. FDA recommends