FDA 483 - Amylynne J. Frankel, M.D. - May 28, 2025

An FDA inspection of Advanced Dermatology & Cosmetic Surgery in Spartanburg, SC, a clinical investigator site, revealed significant deficiencies in conducting an investigational study. Observations included failure to follow the investigational plan regarding subject photographs and adverse event evaluation, inadequate case histories with missing clinical assessments, and poor investigational drug accountability and temperature monitoring. These issues indicate a lack of adherence to good clinical practice.