# FDA 483 - Ionetix Corporation - September 26, 2025

Source: https://www.keypedia.com/records/483/ionetix-corporation/e4dbf171-c2d5-4bf5-ad53-dfdad25fb429

> FDA 483 for Ionetix Corporation on September 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionetix Corporation
- Inspection Date: 2025-09-26
- Product Type: drugs
- Office Name: Florida District Office
- Summary: Ionetix Corporation, a PET drug manufacturer in Miami Beach, FL, was cited with six observations during an FDA inspection. The observations highlight significant deficiencies in quality assurance, equipment suitability, supplier qualification, facility contamination control, and adherence to written procedures, indicating a lack of robust controls over critical manufacturing and testing processes. These issues could adversely affect the identity, strength, quality, or purity of their PET drug products.

## Related Officers

- [Dorothy P. Kramer](https://www.keypedia.com/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Special Assistant](https://www.keypedia.com/people/joanne-e-king/39af2e60-385c-4023-a977-a25157b25563)

Company: https://www.keypedia.com/companies/ionetix-corporation/2c35c3f0-9299-4212-8681-56aa19c36ff0

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