FDA WARNING_LETTER - Hetero Labs Limited Unit V - December 16, 2016

FDA WARNING_LETTER for Hetero Labs Limited Unit V on December 16, 2016. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hetero Labs Limited Unit V on December 16, 2016. 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

21 CFR 211.67(a)

21 CFR 210

21 CFR 211.192

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

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

21 U.S.C. 356C(b)

21 CFR 211.22(d)

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Record Information

Company

Hetero Labs Limited Unit V

Inspection Date

December 16, 2016

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Thomas J. Cosgrove

ID: 137ac1a2-0424-451c-a0ef-c758b2e332b9

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