FDA 483 - Church & Dwight Co., Inc. - May 23, 2019

This FDA Form 483 was issued to Church & Dwight Company Inc. in Lakewood, New Jersey, following an inspection of their OTC drug manufacturing facility. The inspection revealed deficiencies across production, laboratory, and quality systems, including inadequate cleaning validation, incomplete laboratory records for reference standards, and insufficient documentation for microbiological testing equipment and batch investigations. These observations indicate a moderate level of non-compliance with good manufacturing practices.