FDA 483 - 3M Company - January 25, 2019

The FDA inspected 3M Company in Saint Paul, MN, a human drug manufacturer, from January 22-25, 2019. The inspection revealed two significant observations related to quality control failures, including the release of drug product lots that did not meet quality criteria and deficiencies in the quality control unit's procedures for training and mock recalls. These issues indicate a lack of adherence to good manufacturing practices.