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

An unannounced comprehensive cGMP Surveillance Inspection of Church & Dwight Co., Inc. in Old Fort, OH, was conducted from June 21 to July 12, 2023. The inspection, carried out under the regulatory framework of Drug Manufacturing Inspections (CPGM 7356.002), covered the manufacturing of over-the-counter (OTC) drug products and Active Pharmaceutical Ingredients (API), specifically Sodium Bicarbonate (SBC) USP grade, which is also a component in hemodialysis (classified as a medical device under 21 CFR 876.5820).

At the conclusion of the inspection, a three-item Form FDA 483, Inspectional Observations, was issued. The main violations included the failure to adequately validate the firm's water system used in drug product manufacturing (21 CFR 211.63), and the absence of written procedures for the preventive maintenance of this critical water system (21 CFR 211.67(b)). Additionally, the inspection identified a lack of appropriate controls over the computer system used for metal content testing, allowing unauthorized deletion of data records by the Quality Management System supervisor (21 CFR 211.68(b)).

Church & Dwight management committed to providing a written response to the Form FDA 483 within 15 working days, addressing the identified deficiencies. For the computer system access issue, management stated corrective action had already been initiated by reassigning administrative access to an IT employee and removing the supervisor's deletion capability.