FDA Inspection
EOS ImagingEOS Imaging – FDA Inspection, Mar 15, 2012
Record Details
This FDA Inspection record concerns EOS Imaging, with an inspection on March 15, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EOS Imaging
- Inspection Date
- March 15, 2012
- Product Type
- Devices
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ID · c90e17f1-a026-4195-a5ae-fa66cbf6c2ac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 780989
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 1020.30(m)(1)Filtration located in useful beam during exposure
- 21 CFR 1020.30(n)Compliance measurement
- 21 CFR 820.184DHR content
- 21 CFR 1002.11Failure to submit
Full citation text and observation details available on the Dashboard.
Other FDA inspections of EOS Imaging
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 19, 2017 | Not classified | Office of Inspections and Investigations |
Other documents for EOS Imaging
- FDA Inspection 1018725 - 2017-05-19
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