FDA WARNING_LETTER - Promed Exports Private Limited - April 03, 2013

FDA WARNING_LETTER for Promed Exports Private Limited on April 03, 2013. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Promed Exports Private Limited on April 03, 2013. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

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

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

21 CFR 211

21 CFR 211.42(c)(10)(v)

21 CFR 210

21 CFR 211.192

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

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

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Record Information

Company

Promed Exports Private Limited

Inspection Date

April 3, 2013

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Michael D. Smedley

ID: 788f9694-5033-4ab5-87d8-fcd7e8b7d750

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