FDA 483 - Brius Technologies Inc. - October 07, 2024

An FDA inspection of Brius Technologies Inc. in Carrollton, TX, revealed significant deficiencies in their quality system for medical devices. The firm failed to timely report Medical Device Reports (MDRs), inadequately documented corrective and preventive actions (CAPAs), and did not properly investigate product complaints or manage nonconforming products. Additionally, equipment maintenance activities lacked proper documentation and clear instructions.