# FDA 483 - Ionetix Corporation - September 14, 2023

Source: https://www.keypedia.com/records/483/ionetix-corporation/bcf92cdd-6eab-495f-8d9d-9da39a2e88fe

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

---

## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2023-09-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Ionetix Corporation, a PET drug manufacturer in El Paso, TX, revealed two significant observations. The firm's facilities were found inadequate for preventing contamination due to a lack of viable surface sampling in critical sterile areas. Additionally, laboratory testing procedures were deficient, specifically regarding the validation of incubation parameters for environmental and personnel monitoring.

## Related Documents

- [483 - 2022-01-24](https://www.keypedia.com/records/483/ionetix-corporation/14301808-b7a6-4a16-b36f-1b97f55ff6d1)
- [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/demario-l-walls/c69c4c87-f001-45ab-8d7b-b45c60226ff1)
- [Margaret M. Annes](https://www.keypedia.com/people/margaret-m-annes/e528fbbe-2a4c-4697-9256-b7f2d0bcd279)

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