FDA WARNING_LETTER - Wyeth Lederle S.p.A - July 20, 2012

FDA WARNING_LETTER for Wyeth Lederle S.p.A on July 20, 2012. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Wyeth Lederle S.p.A on July 20, 2012. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 314.81(b)(1)(ii)

FD&C Act 801(a)(3)

21 CFR 314.81(b)(1)(i)

21 CFR 211

21 U.S.C. 355(k)

21 U.S.C. 356C(a)(1)

21 CFR 210

21 CFR 211.192

21 U.S.C. 331(e)

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

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Record Information

Company

Wyeth Lederle S.p.A

Inspection Date

July 20, 2012

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: fc922d85-8892-47b9-bdf0-79700aa688f4

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