FDA Inspection
Cogentix Medical, Inc.Cogentix Medical, Inc. – FDA Inspection, Feb 11, 2011
Record Details
This FDA Inspection record concerns Cogentix Medical, Inc., with an inspection on February 11, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cogentix Medical, Inc.
- Inspection Date
- February 11, 2011
- Product Type
- Devices
View Company Profile
ID · 5ce1c5e5-f526-4f46-9051-d13c9d4d2587
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 711939
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.30(e)Design review - documentation
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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 |
| May 1, 2013 | 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 831310 - 2013-05-01
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