FDA 483 - BIOGEN, INC - November 02, 2020
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
An FDA inspection of BIOGEN, INC in Cambridge, MA, identified two significant observations. The firm failed to adequately monitor the progress of an investigation under an IND, specifically regarding the trustworthiness and reliability of electronic records and audit trails. Additionally, the inspection found that the sponsor did not obtain sufficient financial information from clinical investigators, impacting the completeness and accuracy of required disclosure statements.
- Person
ID · cd9c8967-b697-4f33-b4a0-ffbad68af2bc