Alexander Khoruts, M.D., Sponsor-Investigator – FDA Inspection, Aug 26, 2024

Record Details

This FDA Inspection record concerns Alexander Khoruts, M.D., Sponsor-Investigator, with an inspection on August 26, 2024, issued by the Center for Biologics Evaluation and Research.

Company: Alexander Khoruts, M.D., Sponsor-Investigator
Inspection Date: August 26, 2024
Office: Center for Biologics Evaluation and Research
Person: Sharon L. Matson (FDA Associated Person)

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ID · f0fe3077-a9fc-45b1-bab3-62d7676aed41

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1247461
FDA center: Biologics
Project area: Vaccines and Allergenic Products

FDA Citations

21 CFR 312.56(c)Annual report
21 CFR 312.53(b)Shipment to unauthorized persons

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FDA Inspection

Alexander Khoruts, M.D., Sponsor-InvestigatorAugust 26, 2024