483
Alvaro J. OcampoFDA 483 - Alvaro J. Ocampo - July 07, 2014
Record Details
An FDA inspection of Future Care Solution, LLC, a clinical investigator in Miami, FL, revealed significant deficiencies in clinical trial conduct. The firm failed to obtain proper informed consent, report adverse effects promptly, maintain adequate case histories, and ensure accurate investigational drug accountability. These issues indicate a serious lack of adherence to regulatory requirements and good clinical practice.
Open in Dashboard
ID · b7e731ac-996d-45c8-be1f-1bf3aab5db59