FDA Inspection
NextPhase Medical DevicesNextPhase Medical Devices – FDA Inspection, Jun 21, 2012
Record Details
This FDA Inspection record concerns NextPhase Medical Devices, with an inspection on June 21, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- NextPhase Medical Devices
- Inspection Date
- June 21, 2012
- Product Type
- Devices
View Company Profile
ID · f54d8fa8-64ad-4a93-b8a9-5177f11c3367
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 787295
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NextPhase Medical Devices
3| Date | Classification | Office | Project area |
|---|---|---|---|
| December 6, 2016 | 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 998478 - 2016-12-06
- FDA Inspection 608671 - 2009-08-18
- FDA Inspection 550580 - 2008-12-05
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