FDA WARNING_LETTER - IsoTis OrthoBiologics, Inc. - October 17, 2025

FDA WARNING_LETTER for IsoTis OrthoBiologics, Inc. on October 17, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for IsoTis OrthoBiologics, Inc. on October 17, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 351(h)

21 CFR 820.75(c)

21 CFR 820.30(g)

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Record Information

Company

IsoTis OrthoBiologics, Inc.

Inspection Date

October 17, 2025

Product Type

devices

Office

Office of Regulatory Programs

People

ID: 916c2859-5b32-4196-8262-318254949828

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