FDA Inspection
WuXi AppTec, Inc.WuXi AppTec, Inc. – FDA Inspection, Sep 10, 2019
Record Details
This FDA Inspection record concerns WuXi AppTec, Inc., with an inspection on September 10, 2019, issued by the Minneapolis District Office, covering medical devices & rad health.
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ID · 06d8371d-5764-45b7-8080-db3bc1fa10ad
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1101548
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 58.10Notifying contractor of GLP status
- 21 CFR 58.105(c)Test article: storage container labeling
- 21 CFR 58.105(d)Test article: reserve sample retention
- 21 CFR 58.120(a)(11)Protocol: date and signature
- 21 CFR 58.120(a)(8)Protocol: dosage
- 21 CFR 58.120(a)(9)Protocol: tests, analyses, and measurements
- 21 CFR 58.120(b)Protocol: approval of changes
- 21 CFR 58.185(a)(10)Final report: names of those involved
- 21 CFR 58.185(a)(9)Final report: circumstances affecting data qual., integrity
- 21 CFR 58.190(a)Archives: data, documentation, specimens
Showing 10 of 19 citations.
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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 | |
| 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 |
| March 27, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for WuXi AppTec, Inc.
- FDA Inspection 1284572 - 2025-08-21
- FDA Inspection 1052461 - 2018-03-30
- FDA Inspection 1002870 - 2017-03-07
- FDA Inspection 946210 - 2015-08-26
- FDA Inspection 920003 - 2015-03-27
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