483
BIOGEN, INCBIOGEN, INC – FDA 483, Oct 20, 2020
Record Details
An FDA inspection of BIOGEN, INC in Cambridge, MA, revealed two significant observations. The firm failed to adequately monitor an IND investigation, specifically regarding the trustworthiness and reliability of electronic records and audit trails. Additionally, the inspection found that the sponsor did not obtain sufficient financial disclosure information from clinical investigators for multiple studies.
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