Warning letterPosted December 9, 2025
FDA warning letter to Envoy Medical Inc.
CGMP/QSR/Medical Devices/Adulterated
FDA posted a warning letter to Envoy Medical Inc. on December 9, 2025; the letter is dated November 11, 2025. Subject: CGMP/QSR/Medical Devices/Adulterated. Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Envoy Medical Inc.
- Subject
- CGMP/QSR/Medical Devices/Adulterated
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2025-11-11
- Posted by FDA
- 2025-12-09
- Source
- FDA warning letters ↗
CFR cited
The record cites 3 sections of 21 CFR Part 820.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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