Becton Dickinson Medical Systems

CLOSEOUT LETTER Becton Dickinson Medical Systems MARCS-CMS 563754 — February 11, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Recipient Name Vincent Forlenza Recipient Title Chairman & CEO Becton Dickinson Medical Systems Becton Dickinson Medical Systems 1 Becton Drive Franklin Lakes , NJ 07417 United States Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Forlenza: The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter CMS # 563754 dated September 14, 2018. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. We acknowledge the closure of the Becton Dickinson (BD) Medical Systems facility located at 9630 S. 54th St., Franklin, WI. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of your corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Blake Bevill, MS Program Division Director OMDRHO Division 2 - Central CC: Kurt Ebenhoe, Director of Quality Management kurt_ebenhoe@bd.com Boris Shkolnik, Jones, WW Vice President Quality Management boris_shkolnik@bd.com Content current as of: 03/04/2019