Innovative Sterilization Technologies LLC

CLOSEOUT LETTER Innovative Sterilization Technologies LLC MARCS-CMS 524761 — December 27, 2022 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: 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 SCohen@ISTSterilization.com 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, /S/ 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 Content current as of: 12/27/2022 Regulated Product(s) Medical Devices