FDA WARNING_LETTER - CoreMedica Laboratories, Inc. - June 18, 2020

FDA WARNING_LETTER for CoreMedica Laboratories, Inc. on June 18, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for CoreMedica Laboratories, Inc. on June 18, 2020. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

21 U.S.C. 351(f)(1)(B)

21 U.S.C. 321(h)

21 U.S.C. 360(k)

21 U.S.C. 360e(a)

21 U.S.C. 352(o)

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Record Information

Company

CoreMedica Laboratories, Inc.

Inspection Date

June 18, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: 0fc72b01-b35e-40aa-a04e-e28f20206118

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