483
Alison R. Sehgal, MDAlison R. Sehgal, MD – FDA 483, Dec 29, 2020
Record Details
An FDA inspection of Alison R. Sehgal, MD, a clinical investigator in Pittsburgh, revealed a significant deviation from an investigational plan. The firm failed to conduct a required repeat bone marrow assessment for a subject with known bone marrow involvement, despite reporting a complete response. This indicates a failure to adhere to established protocol for confirming treatment efficacy.
- Person
View Company Profile
ID · e297855c-dba4-4202-9903-9378807a4ee8
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.