FDA Inspection
DMX IMAGING, LLCDMX IMAGING, LLC – FDA Inspection, Dec 4, 2017
Record Details
This FDA Inspection record concerns DMX IMAGING, LLC, with an inspection on December 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 6dafadc8-6d06-4bb0-89e0-91a100b20e5c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1033872
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DMX IMAGING, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| June 20, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 7, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for DMX IMAGING, LLC
- FDA Inspection 929787 - 2015-06-05
- FDA Inspection 836771 - 2013-06-20
- FDA Inspection 785658 - 2012-06-07
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.