FDA Inspection
EDRD Enterprises IncEDRD Enterprises Inc – FDA Inspection, Mar 1, 2012
Record Details
This FDA Inspection record concerns EDRD Enterprises Inc, with an inspection on March 1, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EDRD Enterprises Inc
- Inspection Date
- March 1, 2012
- Product Type
- Devices
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ID · bbc970c3-e1c4-4f97-bb72-94705f03bbd5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 767428
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(g)Design validation - Risk analysis
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Other FDA inspections of EDRD Enterprises Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 5, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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