FDA Inspection 578780 — Envoy Medical Corporation
The FDA completed an inspection of Envoy Medical Corporation on Apr 30, 2009 in Saint Paul, MN. 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
- Apr 30, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 14517 | 21 CFR 812.35(a)(1) | No approval for changes requiring prior approval |
| 2928 | 21 CFR 812.40 | Sponsors' general responsibilities |