FDA 483 - Cosmetic Group USA, Inc. - April 14, 2021

An FDA inspection of Cosmetic Group USA, Inc. in Sun Valley, CA, revealed significant deficiencies in quality control, personnel training, production yield management, and facility controls. The firm failed to ensure its quality unit properly reviewed production records and investigated deviations, lacked documented training for quality control analysts, and did not establish procedures for theoretical yield determination or proper storage of in-process materials. These issues indicate a lack of adequate controls over drug product manufacturing.