FDA WARNING_LETTER - Fagron Compounding Services - June 28, 2024

FDA WARNING_LETTER for Fagron Compounding Services on June 28, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Fagron Compounding Services on June 28, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 353b(d)(4)

21 U.S.C. 331(d)

21 CFR 211.113(b)

21 U.S.C. 321(p)

21 CFR 211.56(a)

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

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Record Information

Company

Fagron Compounding Services

Inspection Date

June 28, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

F. Gail Bormel (F.)

ID: 4f8f6bf4-aa3b-4792-ad0c-94ef43cad0c3

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