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CLOSEOUT LETTER

Hospira Costa Rica Ltd.


Hospira Costa Rica Ltd.

  

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

 
 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

F. Michael Ball
Chief Executive Officer
Hospira, Inc.
275 North Field Drive
Lake Forest, Illinois 60045
 

JAN 7 2016
 

Dear Mr. Ball:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #331698, dated August 22, 2012). 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.


Sincerely yours,

/S/

Carl Fischer, Ph.D.
Director
Division of International Compliance
Operations
Office of Compliance
Center for Devices and Radiological Health


cc: Isaias Gonzalez
     Director Consumables Operations Costa Rica
     Hospira Costa Rica Ltd.
     Global Park Free Zone
     La Aurora Heredia,
     Costa Rica
     Ms. Amy Giertych
     Hospira Inc.
     600 North Field Drive H2-2N
     Lake Forest, IL 60045