FDA 483 - Becton Dickinson Caribe LTD - November 23, 2021

Becton Dickinson Caribe LTD in Juncos, PR, was inspected from November 8-23, 2021, and received a Form FDA 483 with two observations. The inspection revealed inadequate corrective and preventive action procedures, specifically regarding device component content impacting test results and package integrity issues for distributed products. Additionally, the firm lacked proper documentation for the review and revalidation of processes in response to changes or deviations.