# FDA 483 - Ionetix Corporation - October 25, 2019

Source: https://www.keypedia.com/records/483/ionetix-corporation/499e6b10-4d58-492f-83e4-7269853c32ca

> FDA 483 for Ionetix Corporation on October 25, 2019. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2019-10-25
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Ionetix Corporation, a PET drug manufacturer in Sarasota, FL, revealed significant deficiencies in their quality assurance procedures and manufacturing controls. The firm failed to establish and follow adequate written procedures for document control, product release, aseptic process validation, and material purchasing. Additionally, issues were noted with incomplete master production records, inadequate equipment qualification and maintenance, and insufficient documentation for laboratory equipment monitoring.

## Related Officers

- [Investigator](https://www.keypedia.com/people/noreen-muniz/0bb20d12-62ad-42aa-8b0a-c44b339d413f)

Company: https://www.keypedia.com/companies/ionetix-corporation/6b494747-d73a-46a1-ae3c-8fd8a55fc1a2

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6