FDA Warning Letter — TomboyX, PBC

Case 720849 — FEI 3031304636

The FDA took a Warning Letter action against TomboyX, PBC on December 16, 2025 (Seattle, WA). The action was issued by CDRH and concerns devices products.

Action Details

Facility
TomboyX, PBC
Date
December 16, 2025
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Seattle, WA (United States)