FDA 483 - Biofusion Management and Manufacturing, LLC - February 26, 2025

During an inspection, Biofusion Management and Manufacturing, LLC, a class II medical device manufacturer in Austin, TX, was cited for significant deficiencies across its quality system. Observations included failures in unique device identifier (UDI) labeling and GUDID submission for their SI-Restore Nano BioBlast Screw, lack of equipment calibration and maintenance procedures, and undocumented management reviews, internal quality audits, and personnel training. These issues indicate a broad lack of adherence to regulatory requirements for medical device manufacturing.