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

Source: https://www.globalkeysolutions.net/records/483/isotopia-molecular-imaging-ltd-soreq-site/d3ae5d47-84f5-4572-8805-91e20db3f0ae

> FDA 483 for Isotopia Molecular Imaging Ltd (Soreq Site) on November 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Isotopia Molecular Imaging Ltd (Soreq Site)
- Inspection Date: 2022-11-08
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gavin-t-cua/6f498dd6-2c4b-42e9-8ddc-3c2a7c97afef)
- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.globalkeysolutions.net/companies/isotopia-molecular-imaging-ltd-soreq-site/de2752ce-03f6-48d0-87a1-77ebaa6fbcc8

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1