Center for Immunology Science, LLC – FDA Inspection, Nov 20, 2024

Record Details

This FDA Inspection record concerns Center for Immunology Science, LLC, with an inspection on November 20, 2024, issued by the Los Angeles District Office, covering human drugs.

Company: Center for Immunology Science, LLC
Inspection Date: November 20, 2024
Product Type: Human Drugs
Office: Los Angeles District Office
Person: Samson O. Oluseye (Issuing Officer)

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ID · 7f16dc3c-1661-4b40-b9fc-d48211cb3c9d

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1254663
FDA center: Human Drugs
Project area: Bioresearch Monitoring: Human Drugs
Outcome: Form 483 issued

FDA Citations

21 CFR 312.20(a)Failure to submit an IND
21 CFR 312.62(b)Case history records- inadequate or inadequate

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FDA Inspection

Center for Immunology Science, LLCNovember 20, 2024