483
Steris S.p.A.Steris S.p.A. – FDA 483, Feb 26, 2026
Record Details
Steris S.p.A., a contract sterilizer in Seriate, Italy, was cited for an inadequate risk-based approach to its quality management system. The firm failed to properly evaluate and assess risks associated with dosimeter conditioning wait-times and potential manufacturing defects in its Process Failure Mode Effects Analysis (pFMEA). This indicates a significant deficiency in ensuring the reliability and control of their sterilization processes.
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ID · b762e0ba-a8da-48b3-a5b2-3b34c0eb4a9d
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