FDA EIR - Innovative Sterilization Technologies LLC - December 22, 2014

An FDA inspection of Innovative Sterilization Technologies LLC, a Class II medical device manufacturer located in Dayton, OH, took place from December 18-22, 2014. This initial inspection, prompted by a consumer complaint, assessed major quality system elements including Management, Corrective and Preventive Action, and Production Controls, in accordance with regulatory guidelines for medical device manufacturers (Compliance Program 7382.845).

The inspection identified three significant issues, documented on an FDA-483 form. Firstly, the company lacked established written Medical Device Report (MDR) procedures, crucial for identifying and evaluating reportable adverse events. Secondly, existing complaint handling procedures were inadequate, failing to ensure uniform and timely processing, proper evaluation for MDR reportability, or comprehensive investigation of device-related failures. Lastly, document control procedures were deficient, not adequately covering all required records as per regulatory standards and specifically not controlling the Approved Suppliers list.

Innovative Sterilization Technologies LLC initiated immediate corrective actions during the inspection, developing MDR procedures and bringing the Approved Suppliers list under document control. For the remaining complaint procedure deficiencies, the firm committed to further revisions within 14 days. A complete written response to the FDA-483 observations was due within 15 days of the inspection's conclusion. Management was advised to enhance their understanding of relevant FDA medical device regulations.