FDA 483 - I.T.S. GmbH - November 16, 2023

During an FDA inspection conducted from November 13 to November 16, 2023, medical device manufacturer I.T.S. GmbH, located in Lasnitzhohe, Austria, received a Form FDA 483 detailing three significant observations concerning its quality system. These observations indicate deviations from regulatory expectations for medical device manufacturing. The first observation highlighted inadequacies in the firm's Corrective and Preventive Action (CAPA) procedures. Specifically, investigations into root causes for product dimensional issues were found to be insufficient, and the effectiveness verification for Medical Device Reporting (MDR) communication procedures was incomplete. The second observation noted deficiencies in equipment calibration and maintenance procedures, with discrepancies identified between test equipment box identification and the actual equipment contained within, raising concerns about the reliability of measurement processes. Finally, the inspection revealed that Device History Records (DHRs) lacked complete documentation for the examination and release of device labeling. Label reviews did not consistently include checks for accuracy of control numbers and Unique Device Identification (UDI), and the date of review was frequently omitted, impacting traceability. I.T.S. GmbH has indicated commitments to correct these observations, with promised completion dates of November 24, 2023, for observations related to equipment calibration and labeling, and December 15, 2023, for the CAPA system deficiencies. The firm is responsible for implementing comprehensive corrective actions to address these quality system findings.