FDA WARNING_LETTER - Criticare Technologies, Inc. - May 10, 2024

FDA WARNING_LETTER for Criticare Technologies, Inc. on May 10, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Criticare Technologies, Inc. on May 10, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.30(a)

21 CFR 820.100(a)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 CFR 820.50

21 U.S.C. 351(h)

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Record Information

Company

Criticare Technologies, Inc.

Inspection Date

May 10, 2024

Product Type

Devices

Office

Division of Medical Device and Radiological Health Operations East

People

ID: 557718dd-64ce-437d-9f13-05cea5aa58ab

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