# Mayo Clinic PET Radiochemistry Facility – FDA 483, Jul 17, 2026

Source: https://www.keypedia.com/records/483/mayo-clinic-pet-radiochemistry-facility/e7711e62-77c9-495a-b1b0-fac441b795e6

> FDA 483 for Mayo Clinic PET Radiochemistry Facility on July 17, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mayo Clinic PET Radiochemistry Facility
- Inspection Date: 2026-07-17
- Product Type: drugs
- Office Name: Florida District Office
- Summary: The FDA issued a Form 483 to Mayo Clinic PET Radiochemistry Facility in Jacksonville, FL, following an inspection of their PET manufacturing operations. The inspection revealed significant deficiencies including inadequate facilities for sterile product dispensing, incomplete master production records leading to omitted critical testing, use of unqualified raw material suppliers, and inaccurate laboratory analytical methods. These observations indicate serious concerns regarding product quality, contamination control, and overall compliance with good manufacturing practices.

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## 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/mayo-clinic-pet-radiochemistry-facility/3f17b059-3512-46ce-907d-085486fd23a1

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