FDA Inspection
EPSILON IMAGING, INCEPSILON IMAGING, INC – FDA Inspection, May 23, 2018
Record Details
This FDA Inspection record concerns EPSILON IMAGING, INC, with an inspection on May 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Amy S. Graf (Issuing Officer)
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ID · af7f93c5-0398-4c65-a568-06bbe7dc2308
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052930
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.180Availability
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
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Other FDA inspections of EPSILON IMAGING, INC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 3, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 28, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for EPSILON IMAGING, INC
- FDA Inspection 920667 - 2015-04-03
- FDA Inspection 826079 - 2013-03-28
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