FDA Inspection 951670 — DORO INC ( O/S DORO SAFETY & SECURITY)
The FDA completed an inspection of DORO INC ( O/S DORO SAFETY & SECURITY) on November 5, 2015 in Nepean. 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
- November 5, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nepean (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |