FDA Inspection
Gulf Fiberoptics, Inc.Gulf Fiberoptics, Inc. – FDA Inspection, Sep 17, 2010
Record Details
This FDA Inspection record concerns Gulf Fiberoptics, Inc., with an inspection on September 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gulf Fiberoptics, Inc.
- Inspection Date
- September 17, 2010
- Product Type
- Devices
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ID · 5cabe14e-d9fc-4bfe-82ea-6a062fbe2912
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 680453
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Gulf Fiberoptics, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 23, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 18, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 6, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 3, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Gulf Fiberoptics, Inc.
- FDA Inspection 1200561 - 2023-03-23
- FDA Inspection 1114389 - 2019-12-18
- FDA Inspection 938165 - 2015-08-13
- FDA Inspection 830326 - 2013-05-06
- FDA Inspection 766713 - 2012-02-03
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