FDA 483 - Pausch Medical GmbH - February 24, 2023

An FDA inspection of Pausch Medical GmbH in Erlangen, Germany, revealed a significant issue regarding product reporting. The firm failed to submit required product reports and obtain accession numbers for its Uroview FD and Uroview FD II fluoroscopic x-ray medical device systems prior to their introduction into U.S. commerce. This indicates a serious lapse in regulatory compliance for distributed medical devices.