483
Shaila U. Gogate, M.D.Shaila U. Gogate, M.D. – FDA 483, Apr 24, 2025
Record Details
An FDA inspection of Shaila U. Gogate, M.D. in Denver, CO, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures in subject eligibility screening, inadequate review of adverse events, and issues with informed consent and maintaining accurate case histories. These findings indicate a lack of adherence to study protocols and regulatory requirements, potentially impacting data integrity and subject safety.
- Office
- Denver District Office
- Person
View Company Profile
ID · 0b742ae3-01e5-4347-983b-2a051944c8eb
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.