FDA Inspection
Amplion Clinical Communications, Inc.Amplion Clinical Communications, Inc. – FDA Inspection, Sep 8, 2021
Record Details
This FDA Inspection record concerns Amplion Clinical Communications, Inc., with an inspection on September 8, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 8, 2021
- Product Type
- Devices
View Company Profile
ID · 376230bf-ac49-414c-ac3a-1d63f8bafb0f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1151083
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amplion Clinical Communications, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 16, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 4, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 7, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 5, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 4, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Amplion Clinical Communications, Inc.
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.