FDA Inspection
Gulf Fiberoptics, Inc.Gulf Fiberoptics, Inc. – FDA Inspection, Feb 3, 2012
Record Details
This FDA Inspection record concerns Gulf Fiberoptics, Inc., with an inspection on February 3, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gulf Fiberoptics, Inc.
- Inspection Date
- February 3, 2012
- Product Type
- Devices
View Company Profile
ID · 3446b968-3b31-43d8-9d8a-7b7b158687d4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 766713
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
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 |
| May 3, 2011 | OAI | 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 722292 - 2011-05-03
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