FDA WARNING_LETTER - Sethi Laboratories - March 19, 2021

FDA WARNING_LETTER for Sethi Laboratories on March 19, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sethi Laboratories on March 19, 2021. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

FD&C Act 502(o)

21 U.S.C. 331(a)

21 U.S.C. 331(k)

21 U.S.C. 352(a)

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

21 U.S.C. 321(h)

21 U.S.C. 360(k)

FD&C Act 501(f)(1)(B)

21 U.S.C. 360bbb-3

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Record Information

Company

Sethi Laboratories

Inspection Date

March 19, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy T. Stenzel (Director)

ID: b4119491-c880-4a75-8b01-991b76a535b3

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