483
Lin Shen, M.D.Lin Shen, M.D. – FDA 483, May 6, 2026
Record Details
An FDA inspection of Lin Shen, MD, a clinical investigator in Beijing, revealed significant deficiencies in conducting a clinical investigation. The firm failed to administer chemotherapy according to protocol specifications for multiple subjects in a clinical trial. Additionally, the inspection found issues with maintaining complete source documents, as notepads used for subject assessments were not included in subject data files.
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ID · 8700ce27-dccb-4200-9e7c-7ced56498a08
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