FDA 483 - COSMETIC LABORATORY INC - August 03, 2022

Cosmetic Lab, Inc. in Downey, CA, a contract manufacturer, was cited for significant deficiencies in its quality control and manufacturing processes for OTC drug products like hand sanitizer and SPF. The inspection revealed issues with component identity testing, lack of process and equipment validation, inadequate cleaning validation, and insufficient vendor qualification. Additionally, annual product reviews lacked necessary detail for quality evaluation.