FDA Inspection 1239009 — Levo Medical Corporation
The FDA completed an inspection of Levo Medical Corporation on May 15, 2024 in Victoria. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Victoria (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |