# FDA 483 - WuXi Advanced Therapies - April 17, 2015

Source: https://www.keypedia.com/records/483/wuxi-advanced-therapies/edf594f4-4bfa-46a0-be91-60c08c9553ca

> FDA 483 for WuXi Advanced Therapies on April 17, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi Advanced Therapies
- Inspection Date: 2015-04-17
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of WuXi AppTec, Inc. in Philadelphia, PA, a control laboratory, revealed significant deficiencies in its quality control unit, including incomplete reviews for test result release, lack of assurance for analyst training, and inadequate review of discrepancies. The inspection also cited the firm for failing to justify deviations from written test procedures and for maintaining incomplete laboratory records that lacked essential instrument identification and traceable raw data. These observations indicate a need for improved adherence to established quality and documentation practices.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/wuxi-advanced-therapies/924dfd6d-83e2-4d18-9a4f-183c23595f40)

## Related Officers

- [Consumer Safety Officer at FDA U.S. Food and Drug Administration](https://www.keypedia.com/people/ko-u-min/9bb5f33e-857b-4c6f-a550-fdb439760e30)
- [Consumer Safety Officer ](https://www.keypedia.com/people/anastasia-m-shields/a22b8d52-e3f9-4e61-aa3f-6f03ff2f59df)
- [PreApproval Manager](https://www.keypedia.com/people/gayle-s-lawson/cd8061de-f089-408c-bbfc-c7c7a5635dd7)

Company: https://www.keypedia.com/companies/wuxi-advanced-therapies/2d12016c-2b9d-4b5e-91a8-4f8af5bee2e1

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8