FDA 483 - Crown Laboratories Inc - September 19, 2025

An FDA inspection of Crown Laboratories Inc in Johnson City, TN, revealed significant deficiencies in the firm's quality control unit, particularly concerning the management of corrective and preventive actions (CAPA) and complaint handling processes. The inspection also identified issues with in-process and finished goods sampling, oversight of contract manufacturing organizations (CMO), and personnel training. These observations indicate a need for improved adherence to written procedures and better documentation of quality system activities.