FDA 483 - Kenvue Canada Inc. - April 15, 2025

An FDA inspection of Kenvue Canada Inc. in Guelph revealed significant deficiencies across multiple areas of their non-sterile drug product manufacturing. The firm was cited for inadequate equipment cleaning and maintenance, insufficient production and process controls, and a failure to thoroughly investigate discrepancies and complaints. Additionally, issues were noted with the accuracy checks of computer systems and the reliability of their drug product stability program.