- Medical Devices
Recipient NameScott E. Cohen
Recipient TitlePresident / Chief Executive Officer
- Innovative Sterilization Technologies LLC
7625 Paragon Road
Dayton, OH 45459-4063
- Issuing Office:
- Division of Medical Device and Radiological Health Operations East
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.
Director, Compliance Branch
Office of Medical Device & Radiological Health,
U.S. Food and Drug Administration
Cc: Dave Billman, COO, DBillman@ISTSterilization.com
Randy J. Prebula, email@example.com