FDA WARNING_LETTER - Biopolygen Corp. - August 10, 2021

FDA WARNING_LETTER for Biopolygen Corp. on August 10, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Biopolygen Corp. on August 10, 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

Biopolygen Corp.

Inspection Date

August 10, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Timothy T. Stenzel (Director)

ID: 38e2c863-9711-4d66-81fd-e1fe988f3625

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