FDA Inspection 810454 — Medtronic Vascular, Inc.
The FDA completed an inspection of Medtronic Vascular, Inc. on November 27, 2012 in Santa Rosa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 27, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Santa Rosa, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14523 | 21 CFR 812.43(c) | No investigator agreement |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |