# FDA 483 - Mayo Clinic PET Radiochemistry Facility - April 12, 2019

Source: https://www.globalkeysolutions.net/records/483/mayo-clinic-pet-radiochemistry-facility/88225acb-31ab-4d16-9d9a-5aaef92155d7

> FDA 483 for Mayo Clinic PET Radiochemistry Facility on April 12, 2019. 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: 2019-04-12
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: The FDA issued a Form 483 to Mayo Clinic PET Radiochemistry Facility in Jacksonville, FL, citing significant deficiencies in contamination control and equipment qualification. The inspection revealed inadequate facilities and a failure to properly evaluate disinfectants for aseptic areas, leading to microbial contamination. Additionally, the firm lacked proper documentation to ensure equipment, specifically a laminar flow hood, was suitable for maintaining sterile conditions.

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## Related Officers

- [Libia Lugo](https://www.globalkeysolutions.net/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.globalkeysolutions.net/companies/mayo-clinic-pet-radiochemistry-facility/3f17b059-3512-46ce-907d-085486fd23a1

Office: https://www.globalkeysolutions.net/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9