# FDA 483 - Envoy Medical Corporation - July 02, 2025

Source: https://www.keypedia.com/records/483/envoy-medical-corporation/1c7ca204-7974-459b-913a-8dfa51a7b2ae

> FDA 483 for Envoy Medical Corporation on July 02, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Envoy Medical Corporation
- Inspection Date: 2025-07-02
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Envoy Medical Corporation, a manufacturer of Class III implantable hearing systems in Saint Paul, MN, was cited for significant deficiencies in its quality system. Observations included inadequate control of nonconforming products, unvalidated critical processes, insufficient process monitoring, delayed complaint investigations, and inadequate risk analysis and equipment calibration. These issues indicate a systemic breakdown in ensuring product quality and patient safety.

## Related Officers

- [Investigator ](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/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d