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Fenwal Inc MARCS-CMS 508809 —

Fenwal Inc

United States

Issuing Office:

United States



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10903 New Hampshire Avenue
Silver Spring, MD 20993 

May 05, 2017

Ref: InterSol® Solution (Platelet Additive Solution 3)

Fenwal, Inc. - A Fresenius Kabi Company
Attention: Mr. Barry Hicks
Manager Regulatory Affairs
Three Corporate Drive, Building 3
Lake Zurich, IL. 60047

Dear Mr. Hicks:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CBER-17-01 issued October 14, 2016]. Based on our evaluation, it appears that you have addressed the violation 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.


Mary Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research

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