FDA Inspection
Tenex Health, Inc.Tenex Health, Inc. – FDA Inspection, Feb 23, 2012
Record Details
This FDA Inspection record concerns Tenex Health, Inc., with an inspection on February 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tenex Health, Inc.
- Inspection Date
- February 23, 2012
- Product Type
- Devices
View Company Profile
ID · 79767a44-8848-49e3-90d5-309212b198fd
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 768795
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
13- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
Showing 10 of 13 citations.
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Other FDA inspections of Tenex Health, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 1, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 21, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2014 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 11, 2013 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 2, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Tenex Health, Inc.
- FDA Inspection 1152158 - 2021-09-01
- FDA Inspection 1023654 - 2017-08-21
- FDA Inspection 872655 - 2014-03-17
- FDA Inspection 822791 - 2013-04-11
- FDA Inspection 625866 - 2009-11-02
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