FDA WARNING_LETTER - MAST Biosurgery USA Inc - August 21, 2025

FDA WARNING_LETTER for MAST Biosurgery USA Inc on August 21, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MAST Biosurgery USA Inc on August 21, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 352(t)(2)

FD&C Act 501(h)

21 CFR 803.3

21 CFR 803.50(a)(1)

21 CFR 803.12(a)

FD&C Act 201(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 CFR 803

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Record Information

Company

MAST Biosurgery USA Inc

Inspection Date

August 21, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: d908a43c-4044-41f7-9745-52e4e098d13c

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