FDA Inspection 1302376 — Coeur Inc.
The FDA completed an inspection of Coeur Inc. on February 11, 2026 in Washington, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 11, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Washington, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23024 | ISO 13485:2016 Clause 4.1.5 | Inadequate monitoring and control over outsourced processes |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |