Church & Dwight Co., Inc. – FDA 483, Jul 16, 2026

An FDA inspection of Church & Dwight Co., Inc. in Old Fort, OH, an API and drug manufacturer, revealed two significant observations. The firm's laboratory controls for volumetric solutions lacked scientific justification for expiration periods and adequate re-standardization. Additionally, the computerized control system for drug production had a shared "Guest" login and insufficient traceability for changes to critical process parameters, indicating potential data integrity and quality control deficiencies.