# FDA 483 - WuXi Advanced Therapies - Unknown Date

Source: https://www.keypedia.com/records/483/wuxi-advanced-therapies/924dfd6d-83e2-4d18-9a4f-183c23595f40

> FDA 483 for WuXi Advanced Therapies on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: WuXi Advanced Therapies
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Wuxi Advanced Therapies, a drug product manufacturer in Philadelphia, was cited for significant deficiencies in its aseptic operator qualification program. The inspection revealed issues including inadequate aseptic technique, insufficient training, lack of supervisory oversight, and failure to follow standard operating procedures and batch record instructions during aseptic operations. These conditions indicate a potential risk to product quality and sterility.

## Related Documents

- [483 - 2015-04-17](https://www.keypedia.com/records/483/wuxi-advanced-therapies/edf594f4-4bfa-46a0-be91-60c08c9553ca)

## Related Officers

- [Grace Fornella Cortesini, Biological Reviewer](https://www.keypedia.com/people/grace-fornella-cortesini-biological-reviewer/0acee304-d84f-4221-a1f3-ee07c621bf2a)
- [Brian Friend, Biologist](https://www.keypedia.com/people/brian-friend-biologist/6b3a3836-6a38-495d-85c4-0947b2c6c40b)
- [Kevin Knudson, Biological Reviewer](https://www.keypedia.com/people/kevin-knudson-biological-reviewer/77d857c4-4a30-4d37-b5c7-2191cab7a8b3)
- [Hector A. Carrero](https://www.keypedia.com/people/hector-a-carrero/d696704e-1309-4f01-8f1e-a2b2b639f881)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd