FDA Inspection
ELITechGroup, Inc.ELITechGroup, Inc. – FDA Inspection, May 27, 2015
Record Details
This FDA Inspection record concerns ELITechGroup, Inc., with an inspection on May 27, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ELITechGroup, Inc.
- Inspection Date
- May 27, 2015
- Product Type
- Devices
View Company Profile
ID · f19fc836-e90c-482a-9fa3-2388e45303f8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 930474
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ELITechGroup, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 22, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 1, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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