FDA Inspection
W. L. Gore & Associates, Inc.W. L. Gore & Associates, Inc. – FDA Inspection, Jul 26, 2018
Record Details
This FDA Inspection record concerns W. L. Gore & Associates, Inc., with an inspection on July 26, 2018, issued by the Denver District Office, covering medical devices & rad health.
- Inspection Date
- July 26, 2018
- Product Type
- Medical Devices & Rad Health
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ID · 8b149b70-05bd-4dd4-a7b9-ed31dc69c2d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060814
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 58.35(a)QAU: monitor facilities, etc.
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Other FDA inspections of W. L. Gore & Associates, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for W. L. Gore & Associates, Inc.
- FDA Inspection 1035576 - 2017-11-17
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