FDA Inspection
Medivators, Inc.Medivators, Inc. – FDA Inspection, Jun 4, 2010
Record Details
This FDA Inspection record concerns Medivators, Inc., with an inspection on June 4, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medivators, Inc.
- Inspection Date
- June 4, 2010
- Product Type
- Devices
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ID · 7d1dad2e-b481-4f87-8605-f212a060d903
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 667132
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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Other FDA inspections of Medivators, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 12, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 31, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 26, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 12, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Medivators, Inc.
- FDA Inspection 927523 - 2015-05-12
- FDA Inspection 890263 - 2014-07-31
- FDA Inspection 742247 - 2011-08-26
- FDA Inspection 672894 - 2010-07-12
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