FDA 483 - Concept Laboratories, Inc. - November 15, 2019

An FDA inspection of Concept Laboratories, Inc. in Chicago, IL, revealed significant deficiencies in quality control, facility maintenance, production procedures, equipment design, supplier qualification, and employee training. The firm manufactures OTC drug products such as Hydrocortisone Cream and Capsaicin Pain Relief Lotion. These issues indicate a lack of adequate controls to ensure drug product quality and safety.