FDA WARNING_LETTER - Claris Injectables Limited - August 04, 2017

FDA WARNING_LETTER for Claris Injectables Limited on August 04, 2017. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Claris Injectables Limited on August 04, 2017. 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 211.58

21 CFR 211

21 CFR 211.188

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)

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Record Information

Company

Claris Injectables Limited

Inspection Date

August 4, 2017

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: d6564925-c7a1-4680-bd5d-d7c326d5bc4e

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