MAST Biosurgery USA Inc – FDA 483, Aug 21, 2025

During an FDA inspection conducted from August 18-21, 2025, MAST Biosurgery USA Inc. received a Form FDA 483 detailing significant observations of non-compliance with regulatory requirements. The primary issues identified included a failure to adequately establish procedures to prevent product contamination, specifically the absence of LAL endotoxin testing for a distributed product since 2021, despite prior commitments, and the lack of a health hazard evaluation.

The inspection also revealed inadequate documentation and implementation of corrective and preventive action (CAPA) activities. This encompassed not opening CAPAs for previous FDA 483 observations, establishing insufficient effectiveness follow-up periods, and completing CAPA investigations and verifications past their due dates. Complaint handling was also cited, with inadequately performed risk assessments and instances where serious adverse events were reclassified as "feedback" to bypass thorough investigation, with key steps remaining undocumented. Finally, the firm failed to provide correct Unique Device Identifier (UDI) information to the FDA's Global UDI Database (GUDID) for products distributed since 2021, with most registrations only completed during the inspection. MAST Biosurgery USA Inc. has committed to correcting these observations, necessitating a comprehensive remediation of their quality management system to achieve full compliance.