483
Isotopia Molecular Imaging Ltd (Soreq Site)Isotopia Molecular Imaging Ltd (Soreq Site) – FDA 483, Nov 8, 2022
Record Details
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.
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ID · d3ae5d47-84f5-4572-8805-91e20db3f0ae
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