FDA Inspection
Medical Energy, Inc.Medical Energy, Inc. – FDA Inspection, Jun 23, 2010
Record Details
This FDA Inspection record concerns Medical Energy, Inc., with an inspection on June 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Medical Energy, Inc.
- Inspection Date
- June 23, 2010
- Product Type
- Devices
View Company Profile
ID · f2e240c2-fded-4255-b9ef-1301e5dc8598
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 670558
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
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 |
| November 17, 2016 | 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 |
Other documents for Medical Energy, Inc.
- FDA Inspection 1205441 - 2023-05-17
- FDA Inspection 992728 - 2016-11-17
- FDA Inspection 827151 - 2013-04-09
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.