FDA Inspection 1177342 — Sensus Healthcare, Inc.
The FDA completed an inspection of Sensus Healthcare, Inc. on August 5, 2022 in Boca Raton, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 5, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |