FDA 483 - Maria E. De La Torre Silva, MD - July 15, 2025

An FDA inspection of West Palm Quality Research, a clinical investigator in West Palm Beach, FL, revealed significant deficiencies in the conduct of clinical trials. The firm failed to adhere to investigational plans, including not conducting a protocol, enrolling subjects who met exclusion criteria, and administering expired investigational product. Additionally, the firm failed to maintain accurate case histories, with discrepancies noted between dispensed and returned investigational products.