FDA WARNING_LETTER - Annovex Pharma, Inc - September 06, 2024

FDA WARNING_LETTER for Annovex Pharma, Inc on September 06, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Annovex Pharma, Inc on September 06, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 310.305(c)(2)

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

21 U.S.C. 331(d)

21 CFR 211.113(b)

21 CFR 310.305(e)

21 CFR 310.305(d)

21 CFR 211.42(c)(10)(iv)

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

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Record Information

Company

Annovex Pharma, Inc

Inspection Date

September 6, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

F. Gail Bormel (F.)

ID: 30d6a041-96ea-4490-ae01-8eba6a88126f

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