FDA WARNING_LETTER - OSRX, Inc. - October 25, 2024

FDA WARNING_LETTER for OSRX, Inc. on October 25, 2024. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for OSRX, Inc. on October 25, 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 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

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

21 CFR 210

21 U.S.C. 353b

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Record Information

Company

OSRX, Inc.

Inspection Date

October 25, 2024

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

F. Gail Bormel (F.)

ID: 0f7e994f-21bf-42dc-845f-54059e4e49a6

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