FDA Inspection

Stanford University School of Medicine Radioactive Drug Research CommitteeApril 21, 2025

Stanford University School of Medicine Radioactive Drug Research Committee – FDA Inspection, Apr 21, 2025

Record Details

This FDA Inspection record concerns Stanford University School of Medicine Radioactive Drug Research Committee, with an inspection on April 21, 2025, issued by the San Francisco District Office, covering human drugs.

Company: Stanford University School of Medicine Radioactive Drug Research Committee
Inspection Date: April 21, 2025
Product Type: Human Drugs
Office: San Francisco District Office
Person: Kristin M. Abaonza (FDA Associated Person)

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ID · e03c0c14-ac19-46e4-b1a8-348da69eaa1f

Inspection Facts

Inspection number: 1267751
FDA center: Human Drugs
Project area: Bioresearch Monitoring: Human Drugs
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 361.1(d)(5)Obtaining informed consent
21 CFR 361.1(d)(6)Radioactive drug - chemical standard
21 CFR 361.1(d)(6)Radioactive materials for parenteral use - preparation
21 CFR 361.1(f)(1)Packaging, labeling - Rx only

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