FDA 483 - Gershwin Blyden, M.D. - September 12, 2019

An FDA inspection of Gershwin Blyden, M.D. in Hollywood, FL, a clinical investigator, revealed significant deficiencies in the conduct of a clinical study. Observations included subjects being deemed eligible for study participation before all required screening assessments were completed, inaccurate case histories with eligibility forms signed prior to their revision date, and inadequate investigational drug disposition records with discrepancies in dispensed product bottles.