FDA Inspection 935210 — Micro Therapeutics, Inc.
The FDA completed an inspection of Micro Therapeutics, Inc. on July 17, 2015 in Irvine, CA. 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
- July 17, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Irvine, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2949 | 21 CFR 812.46(a) | Sponsor securing investigator compliance |