# Envoy Medical Corporation – FDA Inspection, Jul 2, 2025

Source: https://www.keypedia.com/records/fda_inspections/envoy-medical-corporation/8e8b8808-6831-431e-85d8-46ab940eae90
Source feed: FDA_Inspections

> FDA inspection 1276707 of Envoy Medical Corporation, July 02, 2025. Classification: Official Action Indicated (OAI). 6 citations under 21 CFR part 820. Form 483 issued. 7 other FDA inspections on record for this company.

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## Details

- Record Type: FDA Inspection
- Inspection ID: 1276707
- Company Name: Envoy Medical Corporation
- Inspection Date: 2025-07-02
- Classification: Official Action Indicated (OAI)
- Classification Code: OAI
- Project Area: Compliance: Medical Devices
- Product Type: Medical Devices & Rad Health
- Center: Medical Devices & Rad Health
- Office Name: Center for Devices and Radiological Health
- Citation Count: 6

## Related Documents

- FDA Inspection 1163848 - 2022-02-15
- [FDA Inspection 1042731 - 2018-02-14](https://www.keypedia.com/records/fda_inspections/envoy-medical-corporation/f6226e52-e2d7-40dd-aaa8-efa32caaf368)
- FDA Inspection 989459 - 2016-10-27
- [FDA Inspection 894694 - 2014-09-04](https://www.keypedia.com/records/fda_inspections/envoy-medical-corporation/9aeb36dc-3789-4b52-92d2-bd55e6c07ac1)
- [FDA Inspection 713353 - 2011-03-11](https://www.keypedia.com/records/fda_inspections/envoy-medical-corporation/d9bb0386-2638-41b3-a984-6a8a5d1d7992)

## Related Officers

- [FDA Associated Person](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/envoy-medical-corporation/39863764-03a1-4889-8422-b223d8bb942d

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7