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Innovative Sterilization Technologies LLC MARCS-CMS 524761 —

Medical Devices

Recipient Name
Scott E. Cohen
Recipient Title
President / Chief Executive Officer
Innovative Sterilization Technologies LLC

7625 Paragon Road
Suite A
Dayton, OH 45459-4063
United States

Issuing Office:
Division of Medical Device and Radiological Health Operations East

United States

Dear Mr. Cohen:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter dated March 20, 2019 (WL # 524761). 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.

Sincerely yours,
Gina Brackett
Director, Compliance Branch
Office of Medical Device & Radiological Health, 
Division 1
U.S. Food and Drug Administration

Cc: Dave Billman, COO, DBillman@ISTSterilization.com
      Randy J. Prebula, randy.prebula@hoganlovells.com

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