MAST Biosurgery USA, Inc. Warning Letter Details

Summary

MAST Biosurgery USA, Inc. was found to manufacture surgical polymeric mesh devices (SurgiWrap FROST) in violation of Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820, rendering the products adulterated. During an FDA inspection in August 2025, investigators identified a critical failure to establish adequate procedures preventing product contamination, including a specific gap where the firm did not perform required LAL endotoxin testing on SurgiWrap devices despite pre-market commitments to the FDA in November 2020 to conduct such testing. The firm's September 2025 response to FDA 483 observations was deemed insufficient to address the noted quality system violations.