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CLOSEOUT LETTER

Becton Dickinson Medical Systems MARCS-CMS 563754 —


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

555 Winderley Pl # 200
Maitland, FL 32751
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