FDA WARNING_LETTER - Dalian Lingfa Food Co., Ltd. - January 19, 2024

On June 3, 2024, the FDA issued a Warning Letter to Dengshahe Town Jinzhou Qu Dalian Shi Liaoning Sheng, China, following an inspection from January 17-19, 2024. The facility manufactures refrigerated ready-to-eat (RTE) vacuum-packaged vegetables.

The FDA found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117), rendering the refrigerated RTE vacuum-packaged seasoned bamboo shoot products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violation cited was the failure of the hazard analysis to identify and evaluate the known or reasonably foreseeable hazard of pathogenic bacterial outgrowth and toxin formation, specifically *Clostridium botulinum* (C. botulinum), due to reduced oxygen packaging during processing and storage. The facility's seasoned bamboo shoot products do not undergo measures such as pH reduction, water activity control, lethal heat treatment, or adequate refrigeration to control C. botulinum.

While the firm submitted responses including an updated HACCP plan and monitoring records, the FDA found these inadequate. The monitoring frequency for refrigerated storage was insufficient, with only single temperature checks documented for non-finished and final product storage, rather than continuous monitoring. The firm also failed to provide a revised hazard analysis.

The FDA requires prompt corrective