FDA 483 - Cosmaceutical Research Lab Inc. - June 10, 2022

An FDA inspection of Cosmaceutical Research Lab Inc. in Surrey, a drug manufacturer, revealed significant deficiencies in laboratory controls, investigation procedures, and quality control unit responsibilities. The firm failed to establish adequate microbiological testing methods, properly investigate out-of-specification events and product failures, and maintain appropriate quality control practices including data integrity and equipment cleanliness. These observations indicate a lack of robust quality systems for their OTC drug products.