FDA Inspection 1109656 — Clear Guide Medical, Inc.
The FDA completed an inspection of Clear Guide Medical, Inc. on November 13, 2019 in Baltimore, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 13, 2019
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Baltimore, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |