FDA 483 - InvaGen Pharmaceuticals, Inc. - September 19, 2023

Invagen Pharmaceuticals, Inc. in Central Islip, NY, a drug manufacturer, was cited for five observations during an FDA inspection. The findings indicate significant deficiencies in quality control unit oversight, including unreviewed GMP documents, lack of bulk hold time studies for in-process materials, inadequate testing of labeling and packaging materials, and insufficient equipment cleaning. Additionally, the firm's change control procedures lacked due dates, resulting in numerous open change controls.