FDA EIR - Beigene USA, Inc. - June 02, 2021

FDA EIR for Beigene USA, Inc. on June 02, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA EIR for Beigene USA, Inc. on June 02, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 50.24

21 CFR 11

21 CFR 312.53(c)(1)

21 CFR 314.50(d)(5)

21 CFR 50.25(c)

21 CFR 312

21 CFR 312.23(a)(1)(viii)

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Record Information

Company

Beigene USA, Inc.

Inspection Date

June 2, 2021

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: a0431e75-bf13-4576-8ead-639b4bf987dc

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