FDA Inspection 1119023 — Etymonic Design Inc
The FDA completed an inspection of Etymonic Design Inc on Jan 23, 2020 in Dorchester. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 23, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dorchester (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |