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CLOSEOUT LETTER

Battle Creek Equipment Co. MARCS-CMS 455012 —

Delivery Method:
VIA UPS
Reference #:
2015-DET-09
Product:
Medical Devices

Recipient:
Recipient Name
David Underhill
Recipient Title
President
Battle Creek Equipment Co.

702 S. Reed Road
Fremont, IN 46767-2098
United States

Issuing Office:
Center for Device and Radiological Health

One Montvale Avenue
Stoneham, MA 02180
United States


Dear Mr. Underhill:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter, 2015-DET-09 (CMS Case 455012), issued on April 3, 2015. 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 yours,
/S/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health
Division-1 East
Office of Regulatory Affairs
U.S. Food and Drug Administration