FDA 483 - Kord Strebel, MD - August 25, 2021

An FDA inspection of Kord Strebel, MD in Las Vegas, NV, revealed significant deviations from a clinical study protocol for a Phase 3 trial. The firm failed to conduct investigations in accordance with the signed statement of investigator, citing issues with vital sign measurements, physical examinations, subject follow-up, and investigational product storage temperature records. These findings indicate a lack of adherence to established study protocols and good clinical practice.