FDA EIR - ANI Pharmaceuticals, Inc. - November 18, 2022

FDA EIR for ANI Pharmaceuticals, Inc. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA EIR for ANI Pharmaceuticals, Inc. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.198

21 CFR 211.100(b)

21 CFR 211.198(a)

21 CFR 820.100

21 CFR 211.28(a)

21 CFR 211.192

21 CFR 820.50

21 CFR 211.84(d)(3)

21 CFR 211.56(b)

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Record Information

Company

ANI Pharmaceuticals, Inc.

Inspection Date

November 18, 2022

Product Type

drugs

Office

Office of Pharmaceutical Quality Operations Division III

People

ID: 20b0a03d-6de6-4404-a803-eda321e23de6

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