FDA 483 - Color Design Laboratory Inc. - November 16, 2021

Color Design Laboratory Inc. in Northridge, CA, a contract manufacturer, was inspected and cited for numerous deficiencies in its manufacturing processes for OTC drug products. Key issues include inadequate product testing, lack of stability studies, absence of process validation, and widespread failures in quality control unit procedures and record-keeping. The findings indicate significant non-compliance with GMP regulations, posing risks to drug product quality and purity.