FDA 483 - Greiner Bio-One North America, Inc. - December 13, 2019

An FDA inspection of Greiner Bio-One North America, Inc. in Monroe, NC, a medical device manufacturer, revealed nine significant quality system deficiencies. These included inadequate design validation for the VACUETTE product line, failure to process all medical device complaints, and unsubmitted MDR reports for serious injuries. The firm also demonstrated ineffective corrective actions, unvalidated manufacturing processes, and non-conforming finished device acceptance procedures, indicating systemic issues in regulatory compliance.