FDA Inspection 1037525 — Cordis US Corp
The FDA completed an inspection of Cordis US Corp on January 12, 2018 in Miami Lakes, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 12, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Miami Lakes, FL (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 3038 | 21 CFR 812.150(b)(1) | Sponsor evaluation rpt not timely, distributed |