FDA Inspection
VertiFlex, Inc.VertiFlex, Inc. – FDA Inspection, Jul 25, 2014
Record Details
This FDA Inspection record concerns VertiFlex, Inc., with an inspection on July 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- VertiFlex, Inc.
- Inspection Date
- July 25, 2014
- Product Type
- Devices
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ID · f45711ea-f3cf-41c4-aef4-1e17591efd4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 888763
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 812.140(b)(2)Sponsor device disposition records inadequate
- 21 CFR 812.140(b)(1)Sponsor correspondence records inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of VertiFlex, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 16, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 7, 2008 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for VertiFlex, Inc.
- FDA Inspection 993550 - 2016-07-19
- FDA Inspection 881232 - 2014-05-16
- FDA Inspection 647468 - 2010-02-11
- FDA Inspection 541038 - 2008-10-07
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