FDA 483 - Innovative Sterilization Technologies LLC - April 12, 2017

During an inspection conducted from March 14 to April 12, 2017, the FDA issued a Form 483 to Innovative Sterilization Technologies LLC, a medical device manufacturer in Dayton, Ohio. The observations highlighted significant deficiencies in the company's quality management system, particularly concerning its corrective and preventive action (CAPA) processes, complaint handling, incoming product acceptance procedures, and medical device adverse event reporting. The primary issue involved inadequate CAPA procedures, where the firm failed to clearly define "unfavorable trends" and did not initiate CAPAs despite a high volume of warranty complaints (1,184 for lid assemblies, comprising 78% of all claims). Furthermore, several CAPAs, including those addressing prior inspection findings, were closed without verifying their effectiveness. Repeat observations noted deficiencies in complaint handling, with the firm lacking a defined process for investigating and closing warranty complaints when products were not returned, often simply "voiding" them without documentation or customer communication. Procedures for accepting incoming products were also insufficient, with acceptance tests undefined and sampling plans inadequately established. Finally, the company's medical device reporting procedure lacked a standardized process for determining when an event met the criteria for reporting to the FDA. Innovative Sterilization Technologies LLC is expected to implement comprehensive corrective actions to address these systemic issues and ensure full compliance with quality system regulations.