# FDA 483 - Ionetix Corporation - May 01, 2025

Source: https://www.globalkeysolutions.net/records/483/ionetix-corporation/8a2ae2dc-81e1-4683-bd95-e077c86b21b1

> FDA 483 for Ionetix Corporation on May 01, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2025-05-01
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Ionetix Corporation in Miami, FL, a PET drug manufacturer, was cited for significant deficiencies in facility control, equipment maintenance, laboratory methods, and quality systems during an FDA inspection. The observations highlight issues with contamination prevention in cleanrooms, inadequate equipment setup, conflicting environmental monitoring procedures, insufficient corrective actions for sterility failures, and lack of proper resources for QC personnel, with several issues being repeat observations.

## Related Documents

- [483 - 2022-02-09](https://www.globalkeysolutions.net/records/483/ionetix-corporation/d7f7f5da-4201-4047-9492-4884f1eba635)

## Related Officers

- [Special Assistant](https://www.globalkeysolutions.net/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)
- [Mickell Smith](https://www.globalkeysolutions.net/people/mickell-smith/ef92e41a-a16b-488a-a217-b10b54bb4f73)

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

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