FDA 483 - Shanghai Henlius Biologics Co., Ltd. - August 04, 2023

The FDA conducted an inspection of Shanghai Henlius Biologics Co., Ltd., a manufacturing facility located in Songjiang District, Shanghai, China, from July 26 to August 4, 2023. The inspection revealed several critical observations regarding the company's compliance with regulatory standards.

Key violations identified include inadequate procedures for verifying the absence of contaminants in fill line components, as visible contaminants were observed during a setup on July 31, 2023. Additionally, the ambient storage areas in Building [b] were found to lack proper qualifications, affecting the storage of production chromatography resin and chemicals in Quality Control Rooms.

The inspection also highlighted deficiencies in microbial control procedures. Notably, there was no established procedure for sanitizing sink drains in the Production Suites, and improper handling of disinfecting wipes was observed, potentially leading to microbial cross-contamination.

Furthermore, the firm's procedures supporting the [b](4) Test Method were found lacking in appropriate guidance and documentation. Specifically, the SOP-01444 effective from June 30, 2023, did not provide adequate instructions for performing the [b](4) test, including details on reuse times, storage conditions, and tracking of test materials.

The FDA requires Shanghai Henlius Biologics Co., Ltd. to address these observations by implementing corrective actions to ensure compliance with regulatory standards. The company is encouraged to discuss objections or corrective actions with FDA representatives or submit information to the FDA for review.