FDA Inspection 765950 — Adroit Medical Systems Inc
The FDA completed an inspection of Adroit Medical Systems Inc on January 23, 2012 in Loudon, TN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Loudon, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |