FDA Inspection
WuXi AppTec, Inc.WuXi AppTec, Inc. – FDA Inspection, Jun 11, 2009
Record Details
This FDA Inspection record concerns WuXi AppTec, Inc., with an inspection on June 11, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- WuXi AppTec, Inc.
- Inspection Date
- June 11, 2009
- Product Type
- Drugs
View Company Profile
ID · aa8f4f08-8e5d-4c11-aaf3-cb99f52049b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 588318
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.192Written record of investigation incomplete
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Other FDA inspections of WuXi AppTec, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| August 21, 2025 | Not classified | Minneapolis District Office | |
| September 10, 2019 | OAI | Minneapolis District Office | Project Evaluation: Devices |
| March 30, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 7, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| August 26, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for WuXi AppTec, Inc.
- FDA Inspection 1284572 - 2025-08-21
- FDA Inspection 1101548 - 2019-09-10
- FDA Inspection 1052461 - 2018-03-30
- FDA Inspection 1002870 - 2017-03-07
- FDA Inspection 946210 - 2015-08-26
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