FDA WARNING_LETTER - TomboyX, PBC - December 01, 2025

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

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Record Summary

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

Violation Codes

21 U.S.C. 360(j)

FD&C Act 510(p)

FD&C Act 502(o)

21 U.S.C. 360(p)

21 U.S.C. 360

FD&C Act 201(h)

21 U.S.C. 321(h)

FD&C Act 510

FD&C Act 510(j)

21 U.S.C. 352(o)

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Record Information

Company

TomboyX, PBC

Inspection Date

December 1, 2025

Product Type

Devices

Office

Office of Health Technology 3 (Gastrorenal, ObGyn, General Hospital, and Urology Devices)

People

ID: 9213f6ec-2bde-4ba1-b167-5521f4faf968

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