Western Enterprises/Scott Fetzer Company

CLOSEOUT LETTER Western Enterprises/Scott Fetzer Company MARCS-CMS 441366 — October 09, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Andrew Cheshire Recipient Title President Western Enterprises/Scott Fetzer Company Western Enterprises/Scott Fetzer Company 875 Bussett Road Westlake , OH 44145 United States ACheshire@westernenterprises.com 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. Sincerely, /S/ 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 Content current as of: 10/10/2018