FDA Inspection
Oxford Performance Materials, Inc.Oxford Performance Materials, Inc. – FDA Inspection, Apr 7, 2017
Record Details
This FDA Inspection record concerns Oxford Performance Materials, Inc., with an inspection on April 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 2ba62a91-37de-4c8b-9afb-4897ce672dba
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1007636
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 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
- 21 CFR 820.70(h)Use and removal, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
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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 |
| November 21, 2017 | VAI | 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 1034179 - 2017-11-21
- FDA Inspection 861717 - 2013-12-20
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