FDA WARNING_LETTER - Greenbrier International, Inc - January 18, 2019

FDA WARNING_LETTER for Greenbrier International, Inc on January 18, 2019. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Greenbrier International, Inc on January 18, 2019. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(a)(2)(B)

21 U.S.C. 331(c)

21 U.S.C. 331(a)

FD&C Act 301(c)

21 CFR 211

21 CFR 211.165(a)

21 CFR 210

21 U.S.C. 361(c)

21 CFR 211.84(d)(1)

21 CFR 211.165(b)

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Record Information

Company

Greenbrier International, Inc

Inspection Date

January 18, 2019

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: dc7fc45b-f080-4d19-9a7f-cd6a480fa000

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