FDA Inspection
Medical Energy, Inc.Medical Energy, Inc. – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns Medical Energy, Inc., with an inspection on November 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · c047da45-07af-468c-b960-3be1ea994984
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Medical Energy, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 17, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2013 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 23, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Energy, Inc.
- FDA Inspection 1205441 - 2023-05-17
- FDA Inspection 827151 - 2013-04-09
- FDA Inspection 670558 - 2010-06-23
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