FDA 483 - Thrombolex Inc - March 30, 2023

Thrombolex Inc, a medical device manufacturer in New Britain, PA, was inspected by the FDA from March 29-30, 2023. The inspection revealed one significant observation regarding the firm's failure to submit a Medical Device Report (MDR) for a device malfunction. This malfunction, involving a broken guidewire port on their BASHIR Endovascular Catheter Plus, was likely to cause or contribute to a serious injury if it were to recur.