FDA 483 - BECTON, DICKINSON & CO., (BD) - March 01, 2019

An FDA inspection of BD Life Sciences, Preanalytical Solutions in Sumter, SC, a medical device manufacturer, revealed a significant issue with process control procedures. The firm failed to provide adequate scientific justification for methods used to test the hardness of rubber stoppers, specifically regarding data points, sample dimensions, and indentation position. This indicates a lack of robust scientific backing for critical quality control processes.