Synergy Health Ede BVOctober 9, 2023

FDA 483 - Synergy Health Ede BV - October 09, 2023

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Record Details

An FDA inspection of Synergy Health Ede BV, a device contract sterilizer in Venlo, Netherlands, revealed significant deficiencies. Observations included inadequate procedures for process changes and monitoring of xray sterilization parameters. Additionally, device history records failed to demonstrate processing in accordance with master records for urethral catheters.

Company: Synergy Health Ede BV
Inspection Date: October 9, 2023
Product Type: Device
Office: Foreign - CBER (Bioresearch Monitoring)
Person: Stephen D. Eich (investigator)

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ID · 084f0356-dce4-4e2d-a925-fd2633c92304