FDA WARNING_LETTER - Sagent Pharmaceuticals, Inc. - November 04, 2021

FDA WARNING_LETTER for Sagent Pharmaceuticals, Inc. on November 04, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Sagent Pharmaceuticals, Inc. on November 04, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

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

21 U.S.C. 331(a)

21.U.S.C. 355(a)

21 U.S.C. 331(k)

21 CFR 211

21 U.S.C. 360eee-1

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

21 CFR 210

21 U.S.C. 353b

21 U.S.C. 352(f)(1)

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Record Information

Company

Sagent Pharmaceuticals, Inc.

Inspection Date

November 4, 2021

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: f8f8f0fd-02f3-43f3-af07-7910dce31657

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