FDA 483 - Church & Dwight Co., Inc. - December 17, 2012

An FDA inspection of Church and Dwight Co., Inc. in Old Fort, Ohio, an API manufacturer, revealed significant deficiencies in quality control and facility maintenance. Observations included inadequate water system monitoring, poor equipment and building cleanliness with material build-up and standing water, and a lack of microbial analysis for API release testing. Additionally, the firm failed to fully document investigations, missing critical details and corrective actions.