Envoy Medical Corporation – FDA Inspection, Jul 2, 2025

Record Details

This FDA Inspection record concerns Envoy Medical Corporation, with an inspection on July 2, 2025, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company: Envoy Medical Corporation
Inspection Date: July 2, 2025
Product Type: Medical Devices & Rad Health
Office: Center for Devices and Radiological Health
Person: Christina L. Bigham (FDA Associated Person)

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ID · 8e8b8808-6831-431e-85d8-46ab940eae90

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1276707
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces

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Other FDA inspections of Envoy Medical Corporation

Date	Classification	Office	Project area
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
September 4, 2014	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring
March 11, 2011	VAI	Center for Devices and Radiological Health	Bioresearch Monitoring