FDA WARNING_LETTER - AcelRx Pharmaceuticals, Inc. - February 16, 2021

FDA WARNING_LETTER for AcelRx Pharmaceuticals, Inc. on February 16, 2021. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for AcelRx Pharmaceuticals, Inc. on February 16, 2021. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(a)

21 U.S.C. 352(a)

21 U.S.C. 352(n)

21 U.S.C. 321(n)

21 CFR 202.1(e)(3)(ii)

21 CFR 202.1(e)(5)

21 CFR 202.1(e)(7)(viii)

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Record Information

Company

AcelRx Pharmaceuticals, Inc.

Inspection Date

February 16, 2021

Product Type

Drugs

Office

Office of Prescription Drug Promotion

People

Andrew S.T. Haffer

ID: b4520518-fc8e-4dc4-99a1-07133f814241

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