FDA 483 - Greiner Bio-One North America, Inc. - October 29, 2021

An FDA inspection of Greiner Bio-One North America, Inc., a medical device manufacturer in Monroe, NC, revealed significant deficiencies in their quality system. Observations included inadequate procedures for corrective and preventive actions (CAPA), insufficient training criteria for their eCAPA system, and failures in maintaining quality system records, particularly concerning electronic and hardcopy documentation. These issues indicate a need for improved procedural controls and documentation practices.