483
Aptar Stelmi SAAptar Stelmi SA – FDA 483, May 10, 2016
Record Details
An FDA inspection of Stelmi SA, a component sterilizer in Granville, France, revealed a significant quality system deficiency. The firm failed to thoroughly investigate unexplained discrepancies and out-of-specification results for metal particulates and bioburden, indicating a lack of robust root cause analysis. This could impact the quality and safety of sterilized components.
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ID · 675b9ae5-b771-4b41-ae0c-8bbfbb90b554
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