FDA 483 - Colgate-Palmolive Company - July 15, 2021

An FDA inspection of Colgate-Palmolive Company in Morristown, TN, revealed significant deficiencies in their quality system. Observations included inadequate documentation for Medical Device Reporting (MDR) event files, insufficient process validation procedures for equipment maintenance, and failures in complaint evaluation and investigation. Additionally, the firm lacked adequately established procedures for routine equipment calibration.