FDA Inspection
Cogentix Medical, Inc.Cogentix Medical, Inc. – FDA Inspection, May 1, 2013
Record Details
This FDA Inspection record concerns Cogentix Medical, Inc., with an inspection on May 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cogentix Medical, Inc.
- Inspection Date
- May 1, 2013
- Product Type
- Devices
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ID · 8a35b7d1-9d06-4a5e-96a0-3041f4854baf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 831310
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Cogentix Medical, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 14, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 8, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 11, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cogentix Medical, Inc.
- FDA Inspection 1167401 - 2022-04-14
- FDA Inspection 890802 - 2014-08-08
- FDA Inspection 711939 - 2011-02-11
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