# FDA 483 - WuXi AppTec Inc. - May 05, 2011

Source: https://www.keypedia.com/records/483/wuxi-apptec-inc/d9126a10-d0d6-4138-a225-2cffb1da1c29

> FDA 483 for WuXi AppTec Inc. on May 05, 2011. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi AppTec Inc.
- Inspection Date: 2011-05-05
- Product Type: other
- Office Name: Atlanta District Office
- Summary: Wuxi Apptec, Inc. in Marietta, GA, a control testing laboratory, was cited for four observations during an FDA inspection. The inspection revealed significant issues primarily related to quality system deficiencies, including inadequate personnel training, insufficient complaint handling procedures, poor documentation and follow-up of corrective and preventive actions, and incomplete quality audit records. These findings indicate a moderate level of non-compliance with quality system regulations.

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## Related Officers

- [Trang P. Nguyen](https://www.keypedia.com/people/trang-p-nguyen/667c03c1-8688-4b35-864e-af7faaf58604)
- [Melanie Walker](https://www.keypedia.com/people/melanie-walker/fd9d56d8-ff97-4d11-94de-89711d91e51e)

Company: https://www.keypedia.com/companies/wuxi-apptec-inc/9d289339-3edc-4d2e-aacb-4d849335e75d

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7