483
Washington University School of MedicineWashington University School of Medicine – FDA 483, Mar 21, 2024
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.
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ID · bae6855e-2623-4702-a25c-0be0cd6a4b83
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