FDA 483 - Becton Dickinson Medical Systems - August 01, 2018

Becton Dickinson Medical Systems in Franklin, WI, was inspected for its manufacturing of sterile saline/heparin-filled syringes and received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in environmental controls, contamination prevention, process validation, monitoring, and corrective and preventive actions, indicating a high risk of product contamination and quality issues.