483
Synergy Health Ede BVSynergy Health Ede BV – FDA 483, Oct 9, 2023
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.
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ID · 084f0356-dce4-4e2d-a925-fd2633c92304
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