483
NorthStar Medical Radioisotopes, LLCFDA 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.
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ID · e8840edf-48db-4993-a885-d84dfa288808