FDA 483 - Abbott Laboratories - March 29, 2019

Abbott Laboratories in Abbott Park, IL, was cited for inadequate procedures related to manufacturing material use and removal, specifically concerning particles, dust, and debris generated during the production of reaction tray components for licensed test kits. The inspection also found deficiencies in procedures to prevent contamination of equipment by substances that could adversely affect product quality, with observed debris in non-product contact areas of a manufacturing system. These issues indicate a moderate severity regarding quality control and manufacturing process oversight.