FDA Inspection 1196715 — DORO INC ( O/S DORO SAFETY & SECURITY)
The FDA completed an inspection of DORO INC ( O/S DORO SAFETY & SECURITY) on February 2, 2023 in Nepean. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 2, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nepean (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3837 | 21 CFR 820.25(b) | Training records |