FDA 483 - PETNET Solutions, Inc. - October 17, 2022
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An FDA inspection of PETNet Solutions, Inc. in Cincinnati, OH, a PET drug manufacturer, revealed significant deficiencies in their manufacturing processes. Observations included inadequate equipment cleaning procedures, improper handling of sterile components leading to potential contamination, and a lack of established action limits for radiochemical yield in master production records. These issues indicate a need for improved quality control and adherence to good manufacturing practices.
ID · fc7c7f5d-986c-466b-aace-0fa59542fca7