FDA WARNING_LETTER - Orlane S.A. - April 19, 2012

FDA WARNING_LETTER for Orlane S.A. on April 19, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Orlane S.A. on April 19, 2012. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 207.25(b)(7)

21 U.S.C. 381(o)

21 U.S.C. 360(j)(2)

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

21 U.S.C. 360(i)

21 CFR 207.30(a)

21 U.S.C. 381(a)(3)

21 U.S.C. 352(o)

21 CFR 207.40(b)

21 U.S.C. 331(p)

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Record Information

Company

Orlane S.A.

Inspection Date

April 19, 2012

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Douglas Stearn

ID: 2ad9bd9b-5e04-4877-916f-76668588aea6

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