# FDA 483 - Ionetix Corporation - September 14, 2023

Source: https://www.globalkeysolutions.net/records/483/ionetix-corporation/996d8b24-d64e-46ca-a6fd-e37dfadc708c

> FDA 483 for Ionetix Corporation on September 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2023-09-14
- Product Type: drugs
- Office Name: Division of Southwest Imports
- Summary: Ionetix Corporation in El Paso, TX, a PET drug manufacturer, was cited with two observations during an FDA inspection from September 11-14, 2023. The inspection revealed inadequate facility controls for contamination prevention, specifically lacking viable surface sampling in an ISO 5 hood, and deficiencies in laboratory testing procedures, including unvalidated incubation conditions for environmental and personnel monitoring media. These issues indicate potential risks to product quality and purity.

## Related Documents

- [483 - 2022-01-24](https://www.globalkeysolutions.net/records/483/ionetix-corporation/14301808-b7a6-4a16-b36f-1b97f55ff6d1)
- [483 - 2023-09-14](https://www.globalkeysolutions.net/records/483/ionetix-corporation/bcf92cdd-6eab-495f-8d9d-9da39a2e88fe)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)
- [Margaret M. Annes](https://www.globalkeysolutions.net/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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

Office: https://www.globalkeysolutions.net/offices/division-of-southwest-imports/1a990c0f-8880-49cd-9fdf-e7e450072e5a