FDA 483 - FOAMIX PHARMACEUTICALS, INC. - April 24, 2019

An FDA inspection of FORMIX PHARMACEUTICALS, INC. in Bridgewater, NJ, revealed significant deficiencies in the conduct and oversight of clinical trials. The firm failed to ensure proper monitoring of studies, leading to undetected serious adverse events and non-compliance with protocol requirements. Additionally, unqualified investigators were selected for a drug study, violating selection criteria.