# FDA 483 - Ionetix Corporation - February 09, 2022

Source: https://www.globalkeysolutions.net/records/483/ionetix-corporation/d7f7f5da-4201-4047-9492-4884f1eba635

> FDA 483 for Ionetix Corporation on February 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2022-02-09
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: Ionetix Corporation, a PET drug manufacturer in Miami, FL, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate contamination prevention in cleanrooms, improper equipment installation affecting airflow, and failures in approving specifications and following quality assurance procedures for material release and expiration dating. These issues indicate a lack of robust controls to ensure product quality and purity.

## Related Documents

- [483 - 2025-05-01](https://www.globalkeysolutions.net/records/483/ionetix-corporation/8a2ae2dc-81e1-4683-bd95-e077c86b21b1)

## Related Officers

- [Pharmaceutical Investigator](https://www.globalkeysolutions.net/people/kayla-v-sprague/154cb543-111b-4ad1-b45b-43900df71b90)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

Company: https://www.globalkeysolutions.net/companies/ionetix-corporation/5b2b088c-874e-4273-aacf-690d1bc68f30

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