FDA WARNING_LETTER - Hospira Healthcare India Pvt. Ltd. - April 03, 2018

FDA WARNING_LETTER for Hospira Healthcare India Pvt. Ltd. on April 03, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Hospira Healthcare India Pvt. Ltd. on April 03, 2018. 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 211.165(a)

21 CFR 210

21 CFR 211.192

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

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

21 CFR 211.194(a)

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Record Information

Company

Hospira Healthcare India Pvt. Ltd.

Inspection Date

April 3, 2018

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

ID: f02abefc-9a00-44e8-91f7-319d6970f584

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