# FDA 483 - Avery Dennison Belgie BV - April 23, 2015

Source: https://www.globalkeysolutions.net/records/483/avery-dennison-belgie-bv/62b29434-7d90-4bbd-ba25-37aadb0ffa6f

> FDA 483 for Avery Dennison Belgie BV on April 23, 2015. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avery Dennison Belgie BV
- Inspection Date: 2015-04-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Avery Dennison Belgie, BVBA in Turnhout, Belgium, was inspected by the FDA, revealing a significant issue with design validation for their ChloraShield IV Dressing. The firm failed to ensure the device met defined user needs and intended uses, specifically regarding waterproofing and adherence for seven days. This indicates a moderate severity issue related to product quality and regulatory compliance.

## Related Documents

- [483 - 2023-10-23](https://www.globalkeysolutions.net/records/483/avery-dennison-belgie-bv/0962369a-d584-44d0-89ca-ab3068122ff7)

## Related Officers

- [Regulatory Review Officer](https://www.globalkeysolutions.net/people/quynh-strandberg/9b582ae6-85f9-4163-8ce6-b179c5fd340e)

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

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd