FDA 483 - OMRIX Biopharmaceuticals LTD - February 16, 2020

An FDA inspection of Omrix Biopharmaceuticals Ltd. in Ramat Gan, Israel, from February 16-24, 2020, identified multiple significant deficiencies across manufacturing, environmental controls, and laboratory operations. Key issues included the distribution of products manufactured with unapproved changes, inadequate environmental monitoring in aseptic areas, and failures in laboratory investigation and training procedures. These observations indicate a moderate to severe level of non-compliance with good manufacturing practices, potentially impacting product quality and safety.