FDA WARNING_LETTER - Tubilux Pharma Spa - December 09, 2016

FDA WARNING_LETTER for Tubilux Pharma Spa on December 09, 2016. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Tubilux Pharma Spa on December 09, 2016. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

FD&C Act 801(a)(3)

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

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

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

21 CFR 211.63

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Record Information

Company

Tubilux Pharma Spa

Inspection Date

December 9, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: c8ae5092-6c27-4868-85f5-19a87dfb6509

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