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CLOSEOUT LETTER

Hospira Spa 13/06/2017

Hospira Spa - Close Out Letter 6/13/17


Hospira Spa

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Building 51 Room 4359
Silver Spring, MD 20993-0002 

June 13, 2017

Mr. Nathan Stuart James Trembath
Site Head and Managing Director-Liscate Operations
Hospira Liscate, a Pfizer Company
Via Fosse Ardeatine 2
20060 Liscate
Italy

Reference: FEI 3004640070

Dear Mr. Trembath:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter: 320-15-08, March 31, 2015. 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,
/S/

Christina Alemu-Cruickshank
Compliance Officer
Division of Drug Quality I