FDA WARNING_LETTER - RIJ Pharmaceutical LLC - April 13, 2018

FDA WARNING_LETTER for RIJ Pharmaceutical LLC on April 13, 2018. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for RIJ Pharmaceutical LLC on April 13, 2018. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.160(b)

21 CFR 211

21 CFR 210

21 CFR 211.192

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

21 CFR 211.34

21 CFR 211.194(a)

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

21 CFR 211.22(d)

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Record Information

Company

RIJ Pharmaceutical LLC

Inspection Date

April 13, 2018

Product Type

Drugs

Office

Division of Pharmaceutical Quality Operations I

People

ID: 67c2a869-b06f-4e8a-aefb-4a0911f41b21

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