FDA 483 - Hot Shots Nuclear Medicine, LLC - August 09, 2019
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An FDA inspection of Hot Shots Nuclear Medicine, a PET drug producer in Davenport, IA, revealed significant deficiencies in equipment maintenance, production area cleanliness, and quality control. Observations included issues with the laminar airflow cabinet, use of non-sterile gloves and wipes, lack of environmental monitoring, and failure to investigate unknown peaks in finished drug products. These findings indicate a need for improved controls to ensure the quality and safety of PET drugs.
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