FDA WARNING_LETTER - Vivera Pharmaceuticals, Inc. - April 01, 2021

FDA WARNING_LETTER for Vivera Pharmaceuticals, Inc. on April 01, 2021. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Vivera Pharmaceuticals, Inc. on April 01, 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

Vivera Pharmaceuticals, Inc.

Inspection Date

April 1, 2021

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: f2771172-d359-4b5e-95f0-ebb29db92a64

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