FDA 483 - Lan Luo, M.D., FACC - September 16, 2025

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.