FDA WARNING_LETTER - Sandoz Private Limited - August 29, 2014

FDA WARNING_LETTER for Sandoz Private Limited on August 29, 2014. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sandoz Private Limited on August 29, 2014. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.113(b)

21 CFR 211.42(c)(10)(iv)

21 CFR 211

21 CFR 211.68(b)

21 CFR 211.188(b)

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

21 CFR 210

21 CFR 211.192

21 CFR 211.25(a)

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

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Record Information

Company

Sandoz Private Limited

Inspection Date

August 29, 2014

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: 961f17f8-0070-4828-9dfd-9c168fba224b

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