FDA Inspection 1096799 — Prescient Surgical, Inc.
The FDA completed an inspection of Prescient Surgical, Inc. on Jul 19, 2019 in San Carlos, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 19, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Carlos, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |