Maria E. De La Torre Silva, MD – FDA 483, Jul 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.
ID · b5291641-216e-44e0-80c5-711b684de74c
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