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CLOSEOUT LETTER

Hospira Australia Pty Ltd. Feb 08, 2016

Hospira Australia Pty Ltd. - Close Out Letter 2/8/16


Hospira Australia Pty Ltd.

  

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

Public Health Service
Food and Drug Administration
CENTER FOR DRUG EVALUATION AND RESEARCH
 Office of Manufacturing Quality
Division of Drug Quality-I
10903 New Hampshire Avenue
Building #51, Room 4235
Silver Spring, MD 20993

TELEPHONE: (301) 796-4839
FAX: (301) 847-8742

February 8, 2016

Mr. Andrew Hodder
VP Operations
Hospira Australia Pty. Ltd.
1 Lexia Place
Mulgrave, Victoria 3170
Australia


Dear Mr. Hodder:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter WL 320-14-15 and 9/26/2014. 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/

Rafael Arroyo
Consumer Safety Officer
Division of Drug Quality-1
Global Compliance Branch 2
CDER/OC/OMQ