Invacare Corporation – FDA Inspection, Dec 17, 2010

Record Details

This FDA Inspection record concerns Invacare Corporation, with an inspection on December 17, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Invacare Corporation
Inspection Date: December 17, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 7973092b-5d9e-487a-877e-757d08a43de9

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 677859
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 803.50(a)(2)Individual Report of Malfunction
21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.100(b)Documentation
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
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures

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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