FDA Inspection 800016 — Etymonic Design Inc
The FDA completed an inspection of Etymonic Design Inc on Aug 23, 2012 in Dorchester. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 23, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dorchester (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |