FDA 483 - Dr. J Skinclinic, Inc - March 17, 2022

An FDA inspection of Dr. J Skinclinic, Inc. in Cerritos, CA, revealed significant deficiencies in their manufacturing processes for OTC drug products. The firm failed to perform identity testing for active pharmaceutical ingredients, did not maintain or make readily available critical production and distribution records, and lacked stability data to establish expiration dates. Additionally, the company's quality unit did not conduct required annual product quality reviews for several years.