# FDA 483 - NorthStar Medical Radioisotopes, LLC - August 14, 2019

Source: https://www.keypedia.com/records/483/northstar-medical-radioisotopes-llc/3d90c914-41fc-4420-afd5-a415ab69e418

> FDA 483 for NorthStar Medical Radioisotopes, LLC on August 14, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NorthStar Medical Radioisotopes, LLC
- Inspection Date: 2019-08-14
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: NorthStar Medical Radioisotopes, LLC, an active pharmaceutical ingredient manufacturer in Columbia, MO, was inspected and cited for significant deficiencies in laboratory controls, manufacturing process monitoring, quality control unit procedures, equipment calibration, and out-of-specification investigations. The observations indicate a systemic failure to ensure product quality and purity, particularly concerning their RadioGenix System and Moly-99 products. These issues led to the distribution of potentially non-conforming products and a lack of assurance regarding patient safety.

## Related Documents

- [483 - 2020-01-16](https://www.keypedia.com/records/483/northstar-medical-radioisotopes-llc/e8840edf-48db-4993-a885-d84dfa288808)

## Related Officers

- [Jonathan G Gayechuway](https://www.keypedia.com/people/jonathan-g-gayechuway/25f2cb7c-89c5-40d0-96bb-aac9fe374c47)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [National Expert, Pharmaceutical](https://www.keypedia.com/people/simone-e-pitts/e405f1fc-4aff-4202-b216-ddbdc342d108)

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