FDA Inspection
Medical Decision Network, LLCMedical Decision Network, LLC – FDA Inspection, May 29, 2018
Record Details
This FDA Inspection record concerns Medical Decision Network, LLC, with an inspection on May 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 17c21ad3-7fb1-4b26-8adc-be86dc72cdde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053705
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Medical Decision Network, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 19, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Medical Decision Network, LLC
- FDA Inspection 1221710 - 2023-10-25
- FDA Inspection 1144324 - 2021-05-25
- FDA Inspection 940395 - 2015-08-19
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