FDA WARNING_LETTER - Genlabs Corporation - December 09, 2021

FDA WARNING_LETTER for Genlabs Corporation on December 09, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Genlabs Corporation on December 09, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 331(a)

21 CFR 211

21 U.S.C. 321(g)(1)(B)

21 CFR 211.165(a)

21 U.S.C. 352(c)

21 CFR 210

21 U.S.C. 321(g)(1)(C)

21 CFR 211.165(e)

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

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Record Information

Company

Genlabs Corporation

Inspection Date

December 9, 2021

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations IV

People

ID: d7cf09cb-fcad-45a8-9218-f2be56a48f0a

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