FDA 483 - Becton Dickinson & Co. - July 23, 2021

Becton Dickinson & Co. in Sparks, MD, a medical device manufacturer, received a Form FDA 483 for inadequate documentation of design risk analysis results. The firm failed to properly document new risks and mitigation actions identified during Corrective and Preventive Action (CAPA) investigations for recalled products. This deficiency was observed in relation to BD Phoenix™ AST Indicators and BD MAX™ Enteric Bacterial Panel assay kits, indicating a lack of control over identified risks and failure modes.