FDA 483 - Church & Dwight Canada Corp. - January 17, 2020

An FDA inspection of Church & Dwight Canada Corp. in Montreal, Quebec, revealed significant deficiencies in laboratory controls, record-keeping, and quality assurance processes. Observations included failures to maintain complete testing records, ensure data integrity, conduct annual reserve sample examinations, and follow established quality control procedures. The findings indicate a need for improved adherence to good manufacturing practices, particularly concerning data management and documentation.