# FDA 483 - Wuxi Biologics Co Ltd - May 09, 2023

Source: https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/b7ca3a3a-a99e-4208-8185-bf5f78cafdb6

> FDA 483 for Wuxi Biologics Co Ltd on May 09, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2023-05-09
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: The FDA issued a Form 483 to WuXi Biologics Co. Ltd. following an inspection conducted from April 24 to May 9, 2023, at their Wuxi, Jiangsu, China facility. The observations highlight significant deficiencies in Good Manufacturing Practices (GMP) across multiple areas of drug substance and sterile drug product manufacturing. Key issues identified include inadequate Quality Unit oversight, where drug substance batches were partially released and used in drug products before complete quality review and testing. The Quality Unit also failed to adequately investigate and establish unequivocal root causes for invalidated sterility test failures, and lacked procedures for managing contaminated production cultures. The visual inspection program for drug product vials was found deficient, with acceptance criteria allowing batches containing visible particles to be released, and an insufficient process for evaluating the impact of failed personnel requalification. Further observations noted inadequate cleaning and disinfection practices in aseptic processing areas, particularly concerning sporicidal agent use on non-product contact surfaces. In-process parameter setup and hold time validation studies were deemed insufficient to ensure product quality and consistency, with validation methodologies failing to accurately assess physicochemical stability and worst-case microbial growth scenarios. Documentation for equipment and facility surface cleaning was also found lacking. Finally, the company's labeled maximum reuse times for chromatographic resins exceeded those supported by validation studies, and validation studies incorrectly counted partial loading cycles. WuXi Biologics is required to address these critical observations to ensure compliance with regulatory standards.

## Related Documents

- [EIR - 2021-04-02](https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/8aebda01-8224-46b9-8f4a-85ba517d2732)
- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/ce1e9abe-795e-4422-8c9f-c280cc83102e)
- [483 - 2023-05-09](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/cbe568d3-a88d-4653-bf1e-ac4dd349213d)
- [483 - 2021-04-02](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/c4173103-8401-4432-96e8-f35b570c5cc6)
- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/1e3cf4c9-91d3-4f51-9777-fa2ca89cedb2)

## Related Officers

- [Bo Chi, Ph.D., Microbiologist](https://www.keypedia.com/people/bo-chi-phd-microbiologist/69ddbe08-9e55-44fa-8cc3-96b19c9b21fd)
- [Jun Liu, Ph.D., Senior Biologist](https://www.keypedia.com/people/jun-liu-phd-senior-biologist/b602698c-6139-4860-928f-1c7706da4b54)

Company: https://www.keypedia.com/companies/wuxi-biologics-co-ltd/67a28116-624d-42f6-adae-18cf80094862

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa