483
NorthStar Medical Radioisotopes, LLCNorthStar Medical Radioisotopes, LLC – FDA 483, Jan 16, 2020
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.
View Company Profile
ID · e8840edf-48db-4993-a885-d84dfa288808
Other documents for NorthStar Medical Radioisotopes, LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.