FDA Inspection
Oxford Performance Materials, Inc.Oxford Performance Materials, Inc. – FDA Inspection, Nov 21, 2017
Record Details
This FDA Inspection record concerns Oxford Performance Materials, Inc., with an inspection on November 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 5c9aba2d-e104-4a36-86af-66b9e0842ffc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1034179
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Oxford Performance Materials, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 8, 2026 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 2, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 7, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 20, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Oxford Performance Materials, Inc.
- FDA Inspection 1341198 - 2026-10-08
- FDA Inspection 1245812 - 2024-08-02
- FDA Inspection 1007636 - 2017-04-07
- FDA Inspection 861717 - 2013-12-20
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