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CLOSEOUT LETTER

Terumo Medical Corporation MARCS-CMS 483231 —

Delivery Method:
United Parcel Service
Product:
Medical Devices

Recipient:
Recipient Name
James Rushworth
Recipient Title
President/CEO
Terumo Medical Corporation

2101 Cottontail Lane
Somerset, NJ 08873
United States

Issuing Office:
Division of Medical Device and Radiological Health Operations East

United States


Dear Mr. Rushworth:

The Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter, CMS# 483231, dated March 17, 2016 for your firm’s Elkton, MD location. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these 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/
Gina M. Brackett
Director, Compliance Branch
Office of Medical Devices & Radiological Health
Division One - East

 

 
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