FDA WARNING_LETTER - Industry Lab Diagnostic Partners - December 01, 2020

FDA WARNING_LETTER for Industry Lab Diagnostic Partners on December 01, 2020. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Industry Lab Diagnostic Partners on December 01, 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

Industry Lab Diagnostic Partners

Inspection Date

December 1, 2020

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy Stenzel

ID: a7d0ada3-bc37-48c3-afbb-4df7b987932a

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