FDA Inspection
Tenex Health, Inc.Tenex Health, Inc. – FDA Inspection, Apr 11, 2013
Record Details
This FDA Inspection record concerns Tenex Health, Inc., with an inspection on April 11, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tenex Health, Inc.
- Inspection Date
- April 11, 2013
- Product Type
- Devices
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ID · f8daac20-d4a7-431a-bc0d-8428b77db71e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 822791
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
13- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.130Packaging
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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 |
| February 23, 2012 | OAI | Center for Devices and Radiological Health | Compliance: 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 768795 - 2012-02-23
- FDA Inspection 625866 - 2009-11-02
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