FDA Inspection 946247 — National Advanced Endoscopy Devices Inc
The FDA completed an inspection of National Advanced Endoscopy Devices Inc on October 26, 2015 in Canoga Park, CA. 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
- October 26, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Canoga Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |