483
Lan Luo, M.D., FACCLan Luo, M.D., FACC – FDA 483, Sep 16, 2025
Record Details
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.
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ID · 1d5661eb-60ac-4f9f-b6f1-89edeb3abc99
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