Biosensors Interventional Technologies Pte Ltd – FDA 483, Apr 20, 2023

Biosensors Interventional Pte, Ltd. in Singapore was inspected by the FDA from April 17-20, 2023, and received a Form FDA-483 with five observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, complaint handling, medical device reporting (MDR) processes, and process control for their BioFreedom Drug Coated Stent System devices. These issues indicate a lack of adequate quality system implementation for a medical device manufacturer.