FDA Inspection 713353 — Envoy Medical Corporation
The FDA completed an inspection of Envoy Medical Corporation on March 11, 2011 in Saint Paul, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
Postmarket Audit Inspections
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |