FDA WARNING_LETTER - Globus Medical, Inc. - March 07, 2024

FDA WARNING_LETTER for Globus Medical, Inc. on March 07, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Globus Medical, Inc. on March 07, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.100(a)(1)

21 CFR 820.198(c)

21 CFR 803.50(a)(2)

21 CFR 803.18(b)(1)(iii)

21 U.S.C. 351(h)

21 U.S.C. 360i

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Record Information

Company

Globus Medical, Inc.

Inspection Date

March 7, 2024

Product Type

Devices

Office

Office of Medical Device and Radiological Health Division I

People

ID: d08f336b-6d1f-4ade-b7b6-208b562e9557

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