Invacare Corporation – FDA Inspection, Aug 8, 2011

Record Details

This FDA Inspection record concerns Invacare Corporation, with an inspection on August 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Invacare Corporation
Inspection Date: August 8, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · bd6e7a36-4e18-4306-9080-5496588fc0c2

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 738717
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
21 CFR 820.198(a)Complaints
21 CFR 820.100(b)Documentation
21 CFR 820.30(c)Design input - documentation
21 CFR 820.25(a)Personnel
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
21 CFR 820.30(d)Design output - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.250(b)Sampling methods - 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