FDA WARNING_LETTER - www.semaspace.com - October 10, 2023

FDA WARNING_LETTER for www.semaspace.com on October 10, 2023. Product: Drugs. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for www.semaspace.com on October 10, 2023. Product: Drugs. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 331(d)

21 U.S.C. 321(p)

21 U.S.C. 331(a)

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

21 U.S.C. 331(k)

21 U.S.C. 321(g)

21 CFR 201.115(a)

21 U.S.C. 352(f)(1)

21 U.S.C. 353(b)

21 CFR 201.5

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Record Information

Company

www.semaspace.com

Inspection Date

October 10, 2023

Product Type

Drugs

Office

Center for Drug Evaluation and Research

People

Leigh Verbois (Director)

ID: 1215e517-b789-4174-8330-e8030ffcfdac

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