FDA WARNING_LETTER - Cangene BioPharma, LLC - February 18, 2022

FDA WARNING_LETTER for Cangene BioPharma, LLC on February 18, 2022. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Cangene BioPharma, LLC on February 18, 2022. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211

21 CFR 211.67(a)

21 CFR 210

21 U.S.C. 351(a)(2)(B)

21 CFR 211.67(b)

21 CFR 211.34

21 U.S.C. 356C(b)

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Record Information

Company

Cangene BioPharma, LLC

Inspection Date

February 18, 2022

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: fff7ba55-eeac-4a7b-be09-c1d6e3e6ae1e

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