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  5. Western Enterprises/Scott Fetzer Company - 441366 - 10/09/2018
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Western Enterprises/Scott Fetzer Company MARCS-CMS 441366 —

Recipient Name
Andrew Cheshire
Recipient Title
Western Enterprises/Scott Fetzer Company
Western Enterprises/Scott Fetzer Company

875 Bussett Road
Westlake, OH 44145
United States

Issuing Office:
Center for Devices and Radiological Health

6751 Steger Drive
Cincinnati, OH 45237-3097
United States

(513) 679-2700

Dear Mr. Cheshire:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CIN 15-441366-03, dated October 10, 2014. Based on our evaluation, it appears that you have addressed the violations 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 Compliance Branch
Office of Medical Device and Radiological Health Operations Division 1/East

Cc: Chad Gerbick, Director, Quality and Regulatory CGerbick@WesternEnterprises.com

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