FDA Inspection
Envoy Medical CorporationEnvoy Medical Corporation – FDA Inspection, Sep 4, 2014
Record Details
This FDA Inspection record concerns Envoy Medical Corporation, with an inspection on September 4, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Envoy Medical Corporation
- Inspection Date
- September 4, 2014
- Product Type
- Devices
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ID · 9aeb36dc-3789-4b52-92d2-bd55e6c07ac1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 894694
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Envoy Medical Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 2, 2025 | OAI | Center for Devices and Radiological Health | Compliance: Medical Devices |
| February 15, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 14, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 27, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Envoy Medical Corporation
- FDA Inspection 1276707 - 2025-07-02
- FDA Inspection 1163848 - 2022-02-15
- FDA Inspection 1042731 - 2018-02-14
- FDA Inspection 989459 - 2016-10-27
- FDA Inspection 713353 - 2011-03-11
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