FDA Inspection
Kentec Medical, IncKentec Medical, Inc – FDA Inspection, Jul 30, 2018
Record Details
This FDA Inspection record concerns Kentec Medical, Inc, with an inspection on July 30, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 53a53752-8517-4022-8a6e-43817f29509a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060879
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Kentec Medical, Inc
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 19, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 16, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Kentec Medical, Inc
- FDA Inspection 928285 - 2015-05-11
- FDA Inspection 897383 - 2014-09-24
- FDA Inspection 803967 - 2012-10-19
- FDA Inspection 636354 - 2009-12-16
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