FDA 483 - Aptar Stelmi SA - May 10, 2016

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.