# FDA 483 - Avery Dennison Belgie BV - October 23, 2023

Source: https://www.globalkeysolutions.net/records/483/avery-dennison-belgie-bv/0962369a-d584-44d0-89ca-ab3068122ff7

> FDA 483 for Avery Dennison Belgie BV on October 23, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avery Dennison Belgie BV
- Inspection Date: 2023-10-23
- Product Type: device
- Office Name: International Compliance Team
- Summary: An FDA inspection of Avery Dennison Belgie BV, a medical device manufacturer in Turnhout, Antwerpen, Belgium, revealed significant deficiencies in their quality system. Observations included inadequate procedures for process changes and monitoring, as well as shortcomings in the design validation for their Incise Surgical Drape with CHG. These issues suggest a need for improved controls over manufacturing processes and product development.

## Related Documents

- [483 - 2015-04-23](https://www.globalkeysolutions.net/records/483/avery-dennison-belgie-bv/62b29434-7d90-4bbd-ba25-37aadb0ffa6f)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/avery-dennison-belgie-bv/ea71f6af-4bb3-4158-8375-0b29b87a969e

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321