Avery Dennison Belgie BVApril 23, 2015

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

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Record Details

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.

Company: Avery Dennison Belgie BV
Inspection Date: April 23, 2015
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Quynh Strandberg (Regulatory Review Officer)

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ID · 62b29434-7d90-4bbd-ba25-37aadb0ffa6f