FDA 483 - BroadMaster Biotech Corp. - April 13, 2023

BroadMaster Biotech Corp., a medical device manufacturer in Taoyuan City, Taiwan, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, including inadequate complaint handling procedures and a lack of implemented Medical Device Reporting (MDR) procedures. Additionally, personnel demonstrated unfamiliarity with USFDA regulations for exporting medical devices to the US market, indicating a general lack of compliance with critical regulatory requirements.