FDA WARNING_LETTER - Block Scientific - February 05, 2021

FDA WARNING_LETTER for Block Scientific on February 05, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Block Scientific on February 05, 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. 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

Block Scientific

Inspection Date

February 5, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: 835833e7-b901-40c9-9cec-a31f7c1ed44c

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