# FDA WARNING_LETTER - TomboyX, PBC - December 01, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/tomboyx-pbc/9213f6ec-2bde-4ba1-b167-5521f4faf968

> FDA WARNING_LETTER for TomboyX, PBC on December 01, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: TomboyX, PBC
- 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)
- [Fran Dunaway](https://www.globalkeysolutions.net/people/fran-dunaway/93896b72-17bf-4a3d-9bd4-4d53f12badef)

Company: https://www.globalkeysolutions.net/companies/tomboyx-pbc/dff5a805-590a-4aef-8878-8c25198ae9c5

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