FDA WARNING_LETTER - Thermoteknix System Limited - February 22, 2021

FDA WARNING_LETTER for Thermoteknix System Limited on February 22, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Thermoteknix System Limited on February 22, 2021. 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. 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

Thermoteknix System Limited

Inspection Date

February 22, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Courtney H. Lias (Acting Director)

ID: a70dcb6b-5f9e-45d5-a199-a02c81fe3979

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