# Edlen Imaging, LLC – FDA Inspection, Oct 12, 2017

Source: https://www.keypedia.com/records/fda_inspections/edlen-imaging-llc/a6761aa6-7c98-41e3-944e-a9b8aa90095a
Source feed: FDA_Inspections

> FDA inspection 1028486 of Edlen Imaging, LLC, October 12, 2017. Classification: Voluntary Action Indicated (VAI). 4 citations under 21 CFR parts 803 and 820. Form 483 issued.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1028486
- Company Name: Edlen Imaging, LLC
- Inspection Date: 2017-10-12
- Classification: Voluntary Action Indicated (VAI)
- Classification Code: VAI
- Project Area: Compliance: Devices
- Product Type: Devices
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 4

## Related Officers

- [Issuing Officer](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/edlen-imaging-llc/e4226cd3-4747-4a47-8c68-076ae1ef65a6

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7