FDA Inspection 1017646 — Adroit Medical Systems Inc
The FDA completed an inspection of Adroit Medical Systems Inc on Jul 12, 2017 in Loudon, TN. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Loudon, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |