Washington University School of MedicineMarch 21, 2024

FDA 483 - Washington University School of Medicine - March 21, 2024

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Record Details

An FDA inspection of Washington University School of Medicine, a PET Drug Manufacturer in St. Louis, MO, identified two repeat observations related to laboratory controls. The firm failed to establish adequate access controls for analytical equipment, allowing deletion of results without audit trails. Additionally, the analytical laboratory lacked consistent criteria and guidelines for manual integrations of GC chromatograms.

Company: Washington University School of Medicine
Inspection Date: March 21, 2024
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
People: Jacob G. Lutz (Investigator)
Matthew M. Schuckmann

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ID · bae6855e-2623-4702-a25c-0be0cd6a4b83