# FDA 483 - NorthStar Medical Radioisotopes, LLC - January 16, 2020

Source: https://www.keypedia.com/records/483/northstar-medical-radioisotopes-llc/e8840edf-48db-4993-a885-d84dfa288808

> FDA 483 for NorthStar Medical Radioisotopes, LLC on January 16, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NorthStar Medical Radioisotopes, LLC
- Inspection Date: 2020-01-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of NorthStar Medical Radioisotopes LLC in Columbia, MO, a radiopharmaceutical manufacturer, revealed a significant issue where written production and process control procedures were not followed. Specifically, the firm failed to perform and document environmental monitoring during cleanroom performance qualification. This indicates a lapse in adherence to established operational and quality control protocols.

## Related Documents

- [483 - 2019-08-14](https://www.keypedia.com/records/483/northstar-medical-radioisotopes-llc/3d90c914-41fc-4420-afd5-a415ab69e418)

## Related Officers

- [Investigator](https://www.keypedia.com/people/michele-perry-williams/80741e95-8df3-41c9-b9b8-499fcb97921d)

Company: https://www.keypedia.com/companies/northstar-medical-radioisotopes-llc/50ac465e-bd36-475f-ad12-d814e8bdedf3

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8