FDA Inspection 1119023 — Etymonic Design Inc
The FDA completed an inspection of Etymonic Design Inc on January 23, 2020 in Dorchester. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 23, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: 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 |