# FDA 483 - International Isotopes Inc. - May 10, 2019

Source: https://www.globalkeysolutions.net/records/483/international-isotopes-inc/2a918dad-ac78-4bd9-ae6f-491f26d1b9ac

> FDA 483 for International Isotopes Inc. on May 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: International Isotopes Inc.
- Inspection Date: 2019-05-10
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: International Isotopes Inc. in Idaho Falls, ID, was cited for significant deficiencies in its manufacturing processes for I-131 Solution. Observations included unverified laboratory test methods, lack of water analysis for critical manufacturing water, and insufficient data to support reagent and buffer expiry dates. Additionally, the firm failed to investigate environmental excursions, had inadequate computer system controls allowing data deletion, and lacked a written SOP for its Quality Control Unit.

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## Related Officers

- [Food and Nutration Service ](https://www.globalkeysolutions.net/people/farhana-khan/2388f1b3-b96c-4ae9-a520-d469ef762ce9)

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

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822