483
Synergy Health Radeberg GmbHSynergy Health Radeberg GmbH – FDA 483, Sep 8, 2025
Record Details
Synergy Health Radeberg GmbH, a sterilizer facility in Radeberg, Germany, received two observations during an FDA inspection. The firm failed to adequately review and revalidate process changes, specifically for Change No: 2023-019 and Change No. 2024-Minor 011. Additionally, the firm did not adequately evaluate and investigate nonconforming events NC-83600 and NC95869.
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ID · 6c4372ae-e00e-4eaa-bf07-00c0f26f951d
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