FDA Inspection
NextPhase Medical Devices LLCNextPhase Medical Devices LLC – FDA Inspection, Aug 17, 2011
Record Details
This FDA Inspection record concerns NextPhase Medical Devices LLC, with an inspection on August 17, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 17, 2011
- Product Type
- Devices
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ID · a5e76464-119c-48bb-af14-0cf6bdf59eb1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 740506
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of NextPhase Medical Devices LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 11, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 24, 2022 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 7, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 13, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 24, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for NextPhase Medical Devices LLC
- FDA Inspection 1205707 - 2023-05-11
- FDA Inspection 1173291 - 2022-06-24
- FDA Inspection 1142248 - 2021-05-07
- FDA Inspection 1112801 - 2019-12-13
- FDA Inspection 828777 - 2013-04-24
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