FDA 483 - Ana J. Fandino - May 22, 2013

An FDA inspection of Ana J. Fandino, Clinical Investigator, in Miami, FL, revealed significant deviations in the conduct of clinical investigations. The firm failed to adhere to investigational plans, exhibited poor record-keeping practices with inaccurate data entry, and maintained inadequate security for controlled investigational drugs, leading to theft. These findings indicate serious non-compliance with clinical research requirements.