FDA Inspection 1196889 — Etymonic Design Inc
The FDA completed an inspection of Etymonic Design Inc on Feb 9, 2023 in Dorchester. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 9, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Dorchester (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3425 | 21 CFR 820.50(a)(1) | Evaluation and Selection, Suppliers, Contractors, etc. |