FDA WARNING_LETTER - LEEL Tech - August 28, 2024

FDA WARNING_LETTER for LEEL Tech on August 28, 2024. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for LEEL Tech on August 28, 2024. Product: Devices. Access full analysis and detailed observations.

Violation Codes

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

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

21 U.S.C. 331

21 U.S.C. 321(h)

21 U.S.C. 360(k)

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

21 CFR 807.81(a)

21 U.S.C. 352(o)

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Record Information

Company

LEEL Tech

Inspection Date

August 28, 2024

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Binita S. Ashar (Director)

ID: 666f87e9-9f68-46f2-a9d2-0451f667228a

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