FDA Inspection 1095147 — Brain Scientific Inc
The FDA completed an inspection of Brain Scientific Inc on Jul 3, 2019 in Lakewood Ranch, FL. 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 3, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lakewood Ranch, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |