483
Shuo Ma, M.D.FDA 483 - Shuo Ma, M.D. - May 06, 2022
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.
Record Details
An FDA inspection of Shuo Ma, M.D. in Chicago, IL, revealed significant non-compliance with an investigational plan for Protocol EA9161. Key issues included a subject receiving investigational product for an extended period beyond protocol guidelines and the failure to report eleven serious adverse events within required timeframes. Additionally, a subject was administered a drug that should have been withheld during a neutropenia event, contrary to protocol.
Open in Dashboard
ID · 464655d8-9981-47c5-ae4b-64f094e8a429