FDA Inspection
Coeur Inc.Coeur Inc. – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Coeur Inc., with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 98b9abba-e0ba-4b59-a288-f7d1b2e2d48a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1047741
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
Other FDA inspections of Coeur Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 11, 2026 | NAI | Atlanta District Office | Postmarket Assurance: Medical Devices |
| July 28, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 23, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 1, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Coeur Inc.
- FDA Inspection 1302376 - 2026-02-11
- FDA Inspection 988221 - 2016-07-28
- FDA Inspection 795827 - 2012-08-23
- FDA Inspection 572942 - 2009-04-01
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.