FDA Inspection 1096683 — Gauss Surgical, Inc.
The FDA completed an inspection of Gauss Surgical, Inc. on July 18, 2019 in Los Altos, 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
- July 18, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Los Altos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |