FDA 483 - Tongliao Meihua Biological Sci-Tech Co., Ltd. - November 15, 2023

An FDA inspection conducted from November 13-15, 2023, at Tongliao Meihua Biological Sci-Tech Co., Ltd., a manufacturer of human and animal dietary ingredients, identified two significant concerns regarding facility operations. The observations were documented under the Federal Food, Drug, and Cosmetic Act.

Firstly, the company's written supply-chain program for ready-to-eat dietary ingredients, such as L-glutamine and L-isoleucine, did not adequately ensure the control of potential hazards. Specifically, while raw material specifications for corn included testing for several mycotoxins, fumonisin was notably absent from the testing protocol for corn used in L-glutamine and L-isoleucine production. Furthermore, there was no documentation of fumonisin testing for the finished L-glutamine or L-isoleucine products, indicating a gap in their hazard prevention strategy.

Secondly, the facility exhibited inadequate sanitary provisions. Inspectors observed that hand sinks in employee restrooms within the processing plant, where L-glutamine was actively being manufactured, lacked running water, soap, and a means to dry hands. This deficiency in basic hygiene facilities during active production raises concerns about potential contamination risks.

The firm is required to address these observations by discussing any objections or by submitting details of corrective actions already implemented or planned to ensure compliance with regulatory standards.