NorthStar Medical Radioisotopes, LLCJanuary 16, 2020

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

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Record Details

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.

Company: NorthStar Medical Radioisotopes, LLC
Inspection Date: January 16, 2020
Product Type: Drugs
Office: Division of Human and Animal Food Operations - West II
Person: Michele Perry-Williams (Investigator)

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ID · e8840edf-48db-4993-a885-d84dfa288808