FDA WARNING_LETTER - MAST Biosurgery USA Inc - August 21, 2025

The FDA issued a Warning Letter to MAST Biosurgery USA, Inc. following an inspection from August 18 to August 21, 2025, concerning violations in the manufacturing of their SurgiWrap FROST surgical polymeric mesh devices. The primary issues identified involved non-conformity with Quality System regulations and Medical Device Reporting requirements.

Key violations include the failure to establish adequate procedures to prevent product contamination. Despite prior commitments to the FDA to test SurgiWrap FROST for endotoxins and maintain levels below 20 EU/device, the company did not consistently implement this testing, and recent product lots showed significantly higher endotoxin levels. The firm"s proposed higher endotoxin limits were deemed scientifically unjustified. Additionally, MAST Biosurgery USA, Inc. failed to adequately establish and maintain procedures for handling customer complaints, frequently categorizing serious patient events as "feedback" and thus failing to properly document and investigate them within their quality management system.

Furthermore, the company violated Medical Device Reporting regulations by not reporting serious injuries, such as a patient experiencing postoperative ileus requiring medical intervention, within the required 30-day timeframe. The FDA mandates prompt corrective actions, including evaluating and enhancing manufacturing processes for endotoxin control, revising complaint handling procedures for proper documentation and investigation, and ensuring timely reporting of all adverse events. The company must provide evidence of these corrective actions to the FDA.