FDA UNTITLED_LETTER - SKNV - February 13, 2025

FDA UNTITLED_LETTER for SKNV on February 13, 2025. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA UNTITLED_LETTER for SKNV on February 13, 2025. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. § 331(k)

21 CFR 211.42(c)

21 U.S.C. § 351(a)(2)(B)

21 CFR 211.192

21 U.S.C. § 331(a)

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Record Information

Company

SKNV

Inspection Date

February 13, 2025

Product Type

Drugs

Office

Office of Compounding Quality and Compliance

People

Frances G. Bormel (Director)

ID: 9337b56f-44ad-4d0b-a943-fc5aa87632da

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