FDA Inspection 587334 — Cordis Neurovascular, Inc.
The FDA completed an inspection of Cordis Neurovascular, Inc. on May 8, 2009 in Miami Lakes, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- May 8, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami Lakes, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3416 | 21 CFR 820.70(a)(1) | Process control instructions |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |