# FDA WARNING_LETTER - Flux Lab Pte. Ltd. d/b/a The Fluxion - December 01, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/flux-lab-pte-ltd-dba-the-fluxion/fe6e7fd0-f6db-4f76-a027-6e58b20555e2

> FDA WARNING_LETTER for Flux Lab Pte. Ltd. d/b/a The Fluxion on December 01, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Flux Lab Pte. Ltd. d/b/a The Fluxion
- Inspection Date: 2025-12-01
- Product Type: Devices
- Office Name: Office of Health Technology 3 (Gastrorenal, ObGyn, General Hospital, and Urology Devices)

## Related Officers

- [Michael J. Hoffmann](https://www.globalkeysolutions.net/people/michael-j-hoffmann/1c707b34-4901-40fd-ae20-29f5bd7ec0e6)
- [Yan Nie](https://www.globalkeysolutions.net/people/yan-nie/22147f69-27da-4e71-a5f6-48f1db4cb431)

Company: https://www.globalkeysolutions.net/companies/flux-lab-pte-ltd-dba-the-fluxion/d4200fba-3d39-4a1f-997e-c2d40dc2e06f

Office: https://www.globalkeysolutions.net/offices/office-of-health-technology-3-gastrorenal-obgyn-general-hospital-and-urology-devices/7d05e3e5-6274-4a78-971d-69eaa3b2860e