FDA 483 - Formology Lab Inc. - September 09, 2022

Formology Lab Inc. in Chatsworth, CA, a contract manufacturer, was inspected and cited for significant deficiencies across its quality, laboratory, production, materials, and facilities systems. The inspection revealed failures in investigating stability issues, inadequate quality unit responsibilities and procedures, lack of a written stability program, and deficiencies in process validation, water system validation, cleaning validation, and equipment management. These issues indicate a broad lack of adherence to current good manufacturing practices for OTC drug products, particularly SPF products.