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Invacare Corporation MARCS-CMS 617319 —

Medical Devices

Recipient Name
Geoffrey P. Purtill
Recipient Title
President and CEO
Invacare Corporation

One Invacare Way
Elyria, OH 44035
United States

Issuing Office:
Center for Devices and Radiological Health

United States

Dear Mr. Geoffrey P. Purtill:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter WL # 617319 dated November 18, 2021. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Gina M. Brackett, Director of Compliance
Office of Medical Devices & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration

CC: Jason Fiest (VP of Quality and Regulatory Affairs for North America)
Email: jfiest@invacare.com

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