FDA WARNING_LETTER - Auxigen Pharmaceutical, LLC - July 08, 2014

FDA WARNING_LETTER for Auxigen Pharmaceutical, LLC on July 08, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Auxigen Pharmaceutical, LLC on July 08, 2014. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 U.S.C. 351(b)

21 CFR 201.326

21 CFR 211.130

21 U.S.C. 360

21 U.S.C. 352(a)

21 CFR 211

21 U.S.C. 352(f)(2)

21 CFR 211.165(a)

21 U.S.C. 360(j)(1)

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Record Information

Company

Auxigen Pharmaceutical, LLC

Inspection Date

July 8, 2014

Product Type

Drugs

Office

Detroit District Office

People

ID: c961d71a-2326-4928-8ad7-9c948cd4cca9

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