FDA Inspection
W. L. Gore & Associates, Inc.W. L. Gore & Associates, Inc. – FDA Inspection, Mar 21, 2019
Record Details
This FDA Inspection record concerns W. L. Gore & Associates, Inc., with an inspection on March 21, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9a374ca0-c707-44a8-b55e-bc55e5e2695a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1083404
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
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Other FDA inspections of W. L. Gore & Associates, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for W. L. Gore & Associates, Inc.
- FDA Inspection 997735 - 2017-01-11
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