# FDA 483 - Ionetix Corporation - June 04, 2021

Source: https://www.keypedia.com/records/483/ionetix-corporation/23214084-f1e6-4927-bf9c-7987bf61a944

> FDA 483 for Ionetix Corporation on June 04, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2021-06-04
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Ionetix Corp in Pittsburgh, PA, a PET drug establishment, revealed two significant observations. The firm lacked adequate production and process controls to ensure consistent production of a sterile injectable PET drug, specifically regarding environmental monitoring during aseptic processing. Additionally, the facilities were deemed inadequate to prevent contamination, with a lack of supporting data for environmental monitoring plate usage.

## Related Documents

- [483 - 2024-01-19](https://www.keypedia.com/records/483/ionetix-corporation/2d328727-0a12-4201-9371-d954390df7e3)

## Related Officers

- [Program Analyst](https://www.keypedia.com/people/jazmine-n-still/92bc804f-1f4e-46f6-8802-6a65b50f91ae)

Company: https://www.keypedia.com/companies/ionetix-corporation/f5ee63d6-fd81-4213-bcd8-db9bd2ce617f

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8