# FDA 483 - Ionetix Corporation - April 02, 2026

Source: https://www.keypedia.com/records/483/ionetix-corporation/19611088-2e47-431a-8db9-8fc84aeb9f60

> FDA 483 for Ionetix Corporation on April 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2026-04-02
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Ionetix Corporation, a Positron Emission Tomography Drug Manufacturer in Sarasota, FL, was cited for four observations during an FDA inspection. The findings include issues with equipment suitability and maintenance, use of an unreliable component supplier, lack of approved specifications for materials, and deviations from written production and process control procedures. These deficiencies indicate potential risks to the identity, strength, quality, and purity of PET drugs.

## Related Documents

- [483 - 2019-10-25](https://www.keypedia.com/records/483/ionetix-corporation/499e6b10-4d58-492f-83e4-7269853c32ca)

## Related Officers

- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

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

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9