# FDA 483 - Ionetix Corporation - January 24, 2022

Source: https://www.keypedia.com/records/483/ionetix-corporation/14301808-b7a6-4a16-b36f-1b97f55ff6d1

> FDA 483 for Ionetix Corporation on January 24, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2022-01-24
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Ionetix Corporation, a sterile PET human drug manufacturer in El Paso, TX, revealed significant deficiencies in their quality system. Observations included a lack of written procedures for handling system suitability failures, inadequate facility controls to prevent product contamination, and a failure to test container closures according to established specifications. These issues indicate a need for improved quality assurance and control practices.

## Related Documents

- [483 - 2023-09-14](https://www.keypedia.com/records/483/ionetix-corporation/bcf92cdd-6eab-495f-8d9d-9da39a2e88fe)
- [483 - 2023-09-14](https://www.keypedia.com/records/483/ionetix-corporation/996d8b24-d64e-46ca-a6fd-e37dfadc708c)

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.keypedia.com/companies/ionetix-corporation/261f4f76-c14a-4b1c-a49f-eccda86a6a7b

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab