FDA Inspection
The Prometheus GroupThe Prometheus Group – FDA Inspection, Aug 18, 2014
Record Details
This FDA Inspection record concerns The Prometheus Group, with an inspection on August 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Prometheus Group
- Inspection Date
- August 18, 2014
- Product Type
- Devices
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ID · 108c2e78-bd4e-4ae0-9e83-9f9730f9e3e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 891411
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.30(g)Design validation - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Prometheus Group
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 21, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 2, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for The Prometheus Group
- FDA Inspection 1002606 - 2017-02-15
- FDA Inspection 787543 - 2012-06-21
- FDA Inspection 667399 - 2010-06-02
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