Invacare Corporation – FDA Inspection, Dec 9, 2015

Record Details

This FDA Inspection record concerns Invacare Corporation, with an inspection on December 9, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company: Invacare Corporation
Inspection Date: December 9, 2015
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · 80199ca6-3e70-4f43-9a38-20b02a8d98e5

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 940361
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.30(c)Design input - documentation
21 CFR 820.30(g)Design validation - user needs and intended uses
21 CFR 820.30(f)Design verification - output does not meet input requirement
Procedural requirements
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.75(a)Documentation
21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
21 CFR 820.75(b)(2)Documentation of validated process performance

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Invacare Corporation

Date	Classification	Office	Project area
April 9, 2025	Not classified	Cincinnati District Office	Compliance: Medical Devices
March 30, 2023	VAI	Center for Devices and Radiological Health	Compliance: Devices
June 24, 2021	OAI	Center for Devices and Radiological Health	Compliance: Devices
January 31, 2020	NAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices
March 8, 2019	VAI	Center for Devices and Radiological Health	Postmarket Assurance: Devices