FDA Inspection
NextPhase Medical DevicesNextPhase Medical Devices – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns NextPhase Medical Devices, with an inspection on December 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b88c1ebd-6e1e-4bf7-abe9-6db8ce540a1e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 998478
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
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Other FDA inspections of NextPhase Medical Devices
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2008 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for NextPhase Medical Devices
- FDA Inspection 787295 - 2012-06-21
- FDA Inspection 608671 - 2009-08-18
- FDA Inspection 550580 - 2008-12-05
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