FDA Inspection
Vertos Medical, Inc.Vertos Medical, Inc. – FDA Inspection, Jul 25, 2013
Record Details
This FDA Inspection record concerns Vertos Medical, Inc., with an inspection on July 25, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Vertos Medical, Inc.
- Inspection Date
- July 25, 2013
- Product Type
- Devices
View Company Profile
ID · db58c5bd-4826-4a88-88e3-22cd1e23dc41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 842491
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Vertos Medical, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 17, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 10, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 26, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Vertos Medical, Inc.
- FDA Inspection 1205079 - 2023-04-05
- FDA Inspection 1122345 - 2020-03-17
- FDA Inspection 992059 - 2016-11-10
- FDA Inspection 586318 - 2009-05-26
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