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

Source: https://www.globalkeysolutions.net/records/483/kenvue-canada-inc/59e0ac36-0ac1-4da2-9a1e-cf2b9a9fe17f

> FDA 483 for Kenvue Canada Inc. on April 15, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kenvue Canada Inc.
- Inspection Date: 2025-04-15
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [Joseph A. Piechocki](https://www.globalkeysolutions.net/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Drug National Expert](https://www.globalkeysolutions.net/people/sandra-a-boyd/c469103a-0917-407a-b9d1-98273358dfeb)

Company: https://www.globalkeysolutions.net/companies/kenvue-canada-inc/5ebdb680-6bdf-4d05-887c-3d175e32f038

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8