483
Rowena Punzalan, M.D.FDA 483 - Rowena Punzalan, M.D. - January 15, 2021
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
Dr. Rowena Punzalan, a Clinical Investigator in Milwaukee, was issued a Form FDA 483 following an inspection. The inspection revealed that the study site failed to report six protocol deviations to the IRB with the annual report, which was a requirement of the IRB standard operating procedures and the study protocol. This indicates a lapse in adherence to the investigational plan and reporting requirements.
Open in Dashboard
ID · e75ab854-d995-4810-9538-2ff024831e43