483
Molecular Imaging Program at StanfordFDA 483 - Molecular Imaging Program at Stanford - October 04, 2024
Record Details
An FDA inspection of Molecular Imaging Program at Stanford revealed significant deficiencies across multiple areas. The firm failed to establish and follow written quality assurance procedures for cGMP training, deviation handling, environmental monitoring, and clean room certification. Additionally, electronic records lacked adequate controls for user access and audit trails, and expired testing materials were found in storage.
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ID · 814e7cf6-f77c-4913-9962-815bbdb21af9