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  5. Fenwal International Inc - Close Out Letter 4/23/14
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CLOSEOUT LETTER

Fenwal International Inc Apr 23, 2014

Fenwal International Inc - Close Out Letter 4/23/14


Fenwal International Inc

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Food and Drug Administration
 San Juan District
466 Fernandez Juncos Avenue
San Juan PR 00901-3223
Telephone: (787) 729-8500
          FAX: (787) 729·6658

April 23, 2014


CERTIFIED MAIL
RETURN RECEIPT REQUESTED


Mr. Christian Hauer, President and CEO
Medical Device Division
Fenwal Fresenius Kabi USA, LLC
Three Corporate Drive 2nd Floor
Lake Zurich, IL 60047


Dear Mr. Hauer:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter 13-SJN-WL-05 dated 08/16/2013. Based on our evaluation, it appears that you have addressed the violations 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.

 

Kind regards,

/S/

Edwin Ramos
Director Compliance Branch
San Juan District Office

 

cc:
Mr. Manuel Palma
General Plant Manager
Fenwal, a Fresenius-Kabi Company
P.O. Box 832
Maricao, PR 00606