FDA Inspection 1105964 — Tusker Medical, Inc.
The FDA completed an inspection of Tusker Medical, Inc. on October 8, 2019 in Menlo Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 8, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Menlo Park, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |
| 2935 | 21 CFR 812.43(b) | Sponsor shipped devices to unqualified person(s) |
| 2944 | 21 CFR 812.43(d) | Monitors not qualified |