FDA 483 - Lan Luo, M.D., FACC - September 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.
An FDA inspection of Ocala Cardiovascular Research in Ocala, FL, revealed significant deficiencies in the conduct of investigational drug studies. The firm failed to adhere to study protocols regarding subject randomization, investigational product administration, and proper collection of safety laboratory specimens. Additionally, issues were noted with investigational product accountability, timely reporting of adverse events, and maintaining accurate and complete case histories.
ID · 1d5661eb-60ac-4f9f-b6f1-89edeb3abc99