FDA WARNING_LETTER - Staska Pharmaceuticals, Inc. - September 18, 2024

FDA WARNING_LETTER for Staska Pharmaceuticals, Inc. on September 18, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Staska Pharmaceuticals, Inc. on September 18, 2024. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 CFR 211.100(a)

21 CFR 211.113(b)

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

21 CFR 211.67(a)

21 U.S.C. 502(f)(1)

21 CFR 211.192

21 CFR 211.25(a)

21 CFR 210.1(b)

21 CFR 200.10(b)

21 CFR 201.115

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Record Information

Company

Staska Pharmaceuticals, Inc.

Inspection Date

September 18, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

F. Gail Bormel (F.)

ID: 512dfaaa-8fc1-41fe-9ba5-3af3e06a6aec

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