FDA 483 - Church & Dwight Co., Inc. - July 12, 2023

An FDA inspection of Church & Dwight Co., Inc. in Old Fort, OH, a manufacturer of Sodium Bicarbonate, USP, revealed significant deficiencies. The firm failed to validate its process water system and lacked written procedures for its maintenance. Additionally, issues with data integrity were noted, as a QMS supervisor had administrative access with delete capabilities to critical test data.