Church & Dwight Co., Inc. – FDA 483, Oct 25, 2024

Church & Dwight Co., Inc. in Lakewood, NJ, received a Form 483 for significant deficiencies in their OTC drug manufacturing operations. Observations included inadequate component testing for harmful impurities, insufficient finished product and stability testing, unqualified equipment, and a lack of proper reserve sample examination procedures. These issues indicate a need for improved quality control and adherence to cGMP regulations.