FDA WARNING_LETTER - MICROspecialties, Inc. - February 18, 2025

FDA WARNING_LETTER for MICROspecialties, Inc. on February 18, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for MICROspecialties, Inc. on February 18, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.80(d)

21 CFR 820.250(b)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.75(a)

21 U.S.C. 351(h)

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Record Information

Company

MICROspecialties, Inc.

Inspection Date

February 18, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: eb8755c7-b7e1-4b8a-a91d-080c34278731

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