# FDA 483 - University of Wisconsin System Radiopharmaceutical Production Facility - May 23, 2019

Source: https://www.keypedia.com/records/483/university-of-wisconsin-system-radiopharmaceutical-production-facility/102df4c9-2486-4435-8fb1-77da992bf6eb

> FDA 483 for University of Wisconsin System Radiopharmaceutical Production Facility on May 23, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: University of Wisconsin System Radiopharmaceutical Production Facility
- Inspection Date: 2019-05-23
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: The FDA inspected the Univ. of Wisconsin Radiopharmaceutical Production Facility in Madison, WI, a PET drug manufacturer. The inspection revealed significant deficiencies in method validation, quality control of supplies, and production and process controls, particularly concerning aseptic operations and environmental monitoring. These issues indicate a lack of assurance in the identity, strength, quality, and purity of their PET drug products.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/university-of-wisconsin-system-radiopharmaceutical-production-facility/528ae7bc-a8fd-4116-9e39-c73c648357e5)

## Related Officers

- [Robert M. Barbosa](https://www.keypedia.com/people/robert-m-barbosa/41672e72-4ddd-4093-8069-6e49f0c8a873)
- [Investigator](https://www.keypedia.com/people/charles-l-zhou/b55d1247-06de-4c7e-80d8-5ed2f801d259)

Company: https://www.keypedia.com/companies/university-of-wisconsin-system-radiopharmaceutical-production-facility/14292d67-6dcf-4614-9b48-dbc89106a6e1

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d