Company
United StatesCoeur Inc., Washington, NC – FDA Inspections
Inspection records and compliance data for Coeur Inc. in Washington, North Carolina. 5 FDA inspections on record, 2 Form 483s, last inspected February 11, 2026.
Company Profile
This profile covers Coeur Inc. based in Washington, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 1
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected April 1, 2009. Last inspected February 11, 2026.
Most cited issue areas
- Inadequate monitoring and control over outsourced processes1 inspection
- Information gathered in feedback process not used as input into risk management1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 11, 2026 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1302376 |
| March 22, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1047741 |
| July 28, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 988221 |
| August 23, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 795827 |
| April 1, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 572942 |
FDA documents
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Company Information
Name
Coeur Inc.
FEI Number
1038185
Address
209 Creekside Dr, Washington, North Carolina 27889, United States
Country
United States
ID: 662d02ad-f9ca-4795-84e4-c95cc022e4f5