FDA 483 - Maria E. De La Torre Silva, MD - July 15, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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