FDA Inspection 770694 — Vivosonic Inc.
The FDA completed an inspection of Vivosonic Inc. on Feb 9, 2012 in Etobicoke. 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
- Feb 9, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Etobicoke (Canada)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |