# FDA 483 - University of Southern California, DBA USC Molecular Imaging Center - August 14, 2019

Source: https://www.keypedia.com/records/483/university-of-southern-california-dba-usc-molecular-imaging-center/be1b592b-30a7-4f26-8291-3cd03951b619

> FDA 483 for University of Southern California, DBA USC Molecular Imaging Center on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Southern California, DBA USC Molecular Imaging Center
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA inspected the University of Southern California, DBA USC Molecular Imaging Center, a PET Drug Manufacturer, from August 6-14, 2019. The inspection revealed significant deficiencies across multiple areas, including unsuitable laboratory analytical methods, incomplete test records, failure to investigate out-of-specification results, inadequate production controls, and non-adherence to quality assurance procedures and equipment calibration protocols. Several observations were noted as repeat findings, indicating persistent issues with the firm's quality systems.

## Related Officers

- [Chemist/Investigator - Pharmaceutical Quality](https://www.keypedia.com/people/walden-h-lee/18131eea-d1cb-47c4-af79-bea22d436031)
- [Uttaniti Limchumroon](https://www.keypedia.com/people/uttaniti-limchumroon/ce890cbf-2f5c-498f-917c-0edf8b10d356)

Company: https://www.keypedia.com/companies/university-of-southern-california-dba-usc-molecular-imaging-center/7756d2aa-1a43-4621-afbd-efff5dffe87c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6