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FDA Warning Letter — MAST Biosurgery USA Inc

Case 720661 — FEI 3004661493

The FDA took a Warning Letter action against MAST Biosurgery USA Inc on December 17, 2025 (San Diego, CA). The action was issued by CDRH and concerns devices products. This facility has 5 or more recent FDA inspections on record.

Action Details

Facility
MAST Biosurgery USA Inc
Date
December 17, 2025
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
San Diego, CA (United States)

Facility

Recent inspections

  • 1157029 (VAI Fri Nov 19 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1065604 (VAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 908953 (VAI Wed Dec 03 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 843883 (NAI Thu Aug 08 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 677463 (VAI Fri Aug 20 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources