FDA 483 - Isotopia Molecular Imaging Ltd (Soreq Site) - November 08, 2022

An FDA inspection of Isotopia Molecular Imaging Ltd (Soreq 81) in Yavne, Israel, identified a significant issue with laboratory controls. The firm failed to validate a container closure integrity testing method using plastic cuvettes, despite routinely using them for a drug product component. This lapse impacts numerous batches of a sterile drug product component manufactured and released since late 2019.