FDA 483 - Synergy Health Ede BV - February 12, 2026
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An FDA inspection of Synergy Health Ede BV, a gamma sterilizer facility in Ede, Netherlands, revealed two significant observations. The firm failed to adequately control production processes, leading to potential underdosing or overdosing of products due to manual entry errors and lack of verification. Additionally, their complaint handling procedures were found to be inadequate, failing to ensure proper investigation and corrective actions for product quality issues.
ID · c5941fed-ba08-4fd4-a024-e2db6b6c48ea