# FDA WARNING_LETTER - ShapeShifter Apparel, LLC - December 01, 2025

Source: https://www.globalkeysolutions.net/records/warning_letter/shapeshifter-apparel-llc/94f5c024-3328-44b0-9832-01d1e2789352

> FDA WARNING_LETTER for ShapeShifter Apparel, LLC on December 01, 2025. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: ShapeShifter Apparel, LLC
- 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)
- [Eli Coughlin-Galbraith](https://www.globalkeysolutions.net/people/eli-coughlin-galbraith/f9533107-2cb6-4592-80f0-168c0f4f6664)

Company: https://www.globalkeysolutions.net/companies/shapeshifter-apparel-llc/0805b273-cb4f-4f1f-ac3f-a47436e97106

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