# FDA 483 - WuXi ATU Co., Ltd. - March 12, 2025

Source: https://www.keypedia.com/records/483/wuxi-atu-co-ltd/07ace13e-c1bf-4b4b-8afc-7f0b1b7d2a00

> FDA 483 for WuXi ATU Co., Ltd. on March 12, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi ATU Co., Ltd.
- Inspection Date: 2025-03-12
- Product Type: biologics
- Office Name: Division of Manufacturing and Product Quality
- Summary: Between March 3 and March 12, 2025, the FDA conducted an inspection of WuXi ATU Co., Ltd., a gene therapy manufacturer in Wuxi, China. The resulting report identifies thirteen major categories of deficiencies regarding compliance with the Federal Food, Drug, and Cosmetic Act and standard manufacturing quality requirements. The primary issues involve poor aseptic processing techniques, such as staff failing to sanitize equipment or change contaminated gloves during sterile operations. Additionally, the facility was poorly maintained, with inspectors noting leaks, visible debris in safety cabinets, and recurring mold in cleanroom environments. Data integrity was also a significant concern, as batch records were not completed at the time of production, and environmental monitoring tests were frequently aborted without investigation into potential contamination levels. Furthermore, the firm failed to adequately investigate failed lab results or establish proper controls over software used to track quality deviations. WuXi ATU is required to address these findings by implementing comprehensive corrective actions and providing a formal response to the FDA detailing how they will improve sanitization, facility maintenance, and documentation oversight to ensure the safety and quality of their gene therapy products.

## Related Documents

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## Related Officers

- [Viviana R. Ramirez](https://www.keypedia.com/people/viviana-r-ramirez/1d34f713-edc8-4776-ad70-28fcd59345de)
- [Timothy Kamaldinov](https://www.keypedia.com/people/timothy-kamaldinov/30dbc3a4-c383-4c18-9d4b-a3b1e6f50860)
- [Biologist at CBER](https://www.keypedia.com/people/massoud-motamed/a8b363de-eb95-4bd3-8c05-9c34bbdbdc8a)

Company: https://www.keypedia.com/companies/wuxi-atu-co-ltd/12f097ce-5a4f-4b66-9bf7-bc54aa280837

Office: https://www.keypedia.com/offices/division-of-manufacturing-and-product-quality/fc43149e-8541-426d-b1cd-b07e8a729a2d