# FDA 483 - International Isotopes Inc. - April 25, 2025

Source: https://www.globalkeysolutions.net/records/483/international-isotopes-inc/f6cbd51e-1050-44bc-b031-50d0ea009e0e

> FDA 483 for International Isotopes Inc. on April 25, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Isotopes Inc.
- Inspection Date: 2025-04-25
- Product Type: drugs
- Office Name: Seattle District Office
- Summary: International Isotopes Inc. in Idaho Falls, ID, a radiopharmaceutical drug manufacturer, was cited for significant deficiencies during an FDA inspection. The observations primarily concern inadequate investigations into product discrepancies and complaints, issues with the accuracy and reproducibility of test methods for radiochemical purity, and a lack of adequately trained and experienced personnel within the Quality Unit. These issues indicate a systemic breakdown in quality control and assurance processes.

## Related Documents

- [483 - 2019-05-10](https://www.globalkeysolutions.net/records/483/international-isotopes-inc/2a918dad-ac78-4bd9-ae6f-491f26d1b9ac)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Investigator](https://www.globalkeysolutions.net/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.globalkeysolutions.net/companies/international-isotopes-inc/45d80b73-be9e-40fb-978b-66683f25c070

Office: https://www.globalkeysolutions.net/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913