FDA WARNING_LETTER - Fareva Morton Grove - August 12, 2025

FDA WARNING_LETTER for Fareva Morton Grove on August 12, 2025. Product: drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Fareva Morton Grove on August 12, 2025. Product: drugs. Access full analysis and detailed observations.

Violation Codes

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

21 CFR 211

21.U.S.C. 331(a)

21 CFR 210

FD&C Act 301(a)

21 U.S.C. 321(i)

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

21 CFR 211.63

FD&C Act 201(i)

21 CFR 211.165(b)

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Record Information

Company

Fareva Morton Grove

Inspection Date

August 12, 2025

Product Type

drugs

Office

Center for Drug Evaluation and Research

People

Bernard Fraisse

ID: 340f3953-dde1-4252-abd2-75bd0c70030c

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