# FDA 483 - Wuxi Biologics Co Ltd - June 04, 2024

Source: https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/f42eaa83-6c51-4d59-9e00-368135ec25aa

> FDA 483 for Wuxi Biologics Co Ltd on June 04, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Wuxi Biologics Co Ltd
- Inspection Date: 2024-06-04
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: WuXi Biologics, a drug substance and drug product manufacturer in Wuxi, Jiangsu, was cited for two observations during an FDA inspection. The firm's performance qualification for a packaging machine was found inadequate, as container closure integrity at higher pressures was not demonstrated, potentially compromising vial integrity. Additionally, in-process control testing for drug products utilized insufficient sample sizes, raising concerns about batch consistency and overall product integrity.

## Related Documents

- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/1e3cf4c9-91d3-4f51-9777-fa2ca89cedb2)
- [EIR - 2021-04-02](https://www.keypedia.com/records/eir/wuxi-biologics-co-ltd/49fcfc39-0021-4cc2-8bce-513930c8167e)
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- [483 - 2019-04-16](https://www.keypedia.com/records/483/wuxi-biologics-co-ltd/ce1e9abe-795e-4422-8c9f-c280cc83102e)

## Related Officers

- [Hamet Touré, PharmD MPH, Regulatory Officer](https://www.keypedia.com/people/hamet-toure-pharmd-mph-regulatory-officer/90e0a7c5-7fff-4dfe-a893-7d7cad038a15)
- [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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd