FDA WARNING_LETTER - Donggang Hongxing Food Co., Ltd. - May 23, 2019

The FDA inspected Donggang Hongxing Food Co., Ltd. in China on May 22-23, 2019, identifying serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) for their frozen boiled short necked clams (vacuum packed). An FDA 483 was issued, and the firm's subsequent response and revised HACCP plan were deemed inadequate, rendering their product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Significant deviations included the failure to have a HACCP plan that lists adequate critical limits (21 CFR 123.6(c)(3)), such as lacking time for pathogen control, proper cooling water treatment, and labeling instructions for thawing to control Clostridium botulinum. The firm also failed to list adequate monitoring procedures and frequencies for critical control points (21 CFR 123.6(c)(4)), with an inappropriate frequency for natural toxin control. Additionally, their HACCP plan's corrective actions were not appropriate (21 CFR 123.7(b)), lacking recommendations like rejecting lots, re-boiling product instead of just testing, and assessing product safety or correcting deviation causes. The firm must respond within 15 working days, detailing corrective steps, providing a revised HACCP plan, and five consecutive days of monitoring records. Failure to comply could lead to refusal of admission (DWPE, e.g., Import Alert #16-120) and assessment of re-inspection fees under Section 743 of the Act. The company is responsible for ensuring compliance with all applicable regulations, including seafood HACCP and Good Manufacturing Practice (21 CFR 117 Subpart B).