FDA 483 - Topical Pharmaceuticals, Inc. - July 01, 2022

An FDA inspection of Topical Pharmaceuticals, Inc. in Addison, IL, from June 28 to July 1, 2022, revealed significant deficiencies in the firm's quality control unit. The company lacked written procedures for critical processes such as tracking out-of-specification investigations and water sampling, and failed to adequately follow established procedures for process validation and corrective and preventive actions. These findings indicate a need for comprehensive improvements in the firm's quality management system.