FDA 483 - Idalia Acosta, M.D. - January 16, 2025
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.
The FDA inspected San Marcus Research Clinic, Inc. in Miami Lakes, FL, as a clinical investigator, revealing significant deficiencies in maintaining adequate and accurate case histories. The inspection found multiple instances of data discrepancies, including conflicting screening weights, inconsistent investigational product accountability, and missing or duplicated source documentation for study subjects. These observations highlight serious concerns regarding the integrity and reliability of clinical trial data at the facility.
ID · 548ad927-84a0-44e2-af6f-5add518194c6