FDA 483 - Kenvue Canada Inc. - April 15, 2025
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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.
ID · 59e0ac36-0ac1-4da2-9a1e-cf2b9a9fe17f