FDA 483 - Becton Dickinson Caribe LTD - March 11, 2020

An FDA inspection of Becton Dickinson Caribe LTD in Cayey, PR, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, and also did not properly control nonconforming products. These issues indicate a lack of adherence to established quality system regulations.