FDA 483 - The Feinstein Institute for Medical Research - May 09, 2025
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The FDA inspected The Feinstein Institute for Medical Research, a PET drug manufacturer, and found significant deficiencies. The firm lacked established written quality assurance procedures for critical operations such as supplier qualification, component handling, and product distribution. Additionally, the inspection revealed severe data integrity issues in the laboratory, where radiochemists had administrative privileges to alter or delete product release testing data.
ID · 9edd5976-ce7f-4f83-a1fb-2f775df96247