FDA Warning Letter — The Fluxion

Case 720847 — FEI 3042197030

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

Action Details

Facility
The Fluxion
Date
December 16, 2025
Fiscal Year
2026
Product Type
Devices
Center
CDRH
Location
Singapore (Singapore)