FDA 483 - Stepac L.A., LTD. - June 22, 2023

An FDA Form 483 was issued to Stepac L.A., LTD., a manufacturer in Tefen, Israel, following an inspection conducted from June 19 to June 22, 2023. The inspection identified seven significant observations, primarily highlighting deficiencies in the firm's quality system procedures and indicating non-compliance with the Code of Federal Regulations (CFR) Part 820, the Quality System Regulation for medical devices.Key issues included the absence of written Medical Device Reporting (MDR) procedures and inadequate protocols for complaint handling, specifically omitting requirements for investigating device failures and events reportable to the FDA. Calibration procedures lacked provisions for remedial action when equipment was found 'out of calibration' and for evaluating its impact on device quality. Furthermore, deficiencies were noted in management review procedures, failing to define essential participants or ensure quality system effectiveness. The firm's quality audit procedures omitted crucial FDA medical device regulations, and supplier control procedures lacked clear definitions for acceptable performance, acceptance criteria, and methods for addressing underperforming suppliers. Lastly, training procedures did not adequately identify training needs related to FDA medical device regulations. Stepac L.A., LTD. has committed to correcting all identified observations to achieve full regulatory compliance.