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CLOSEOUT LETTER

Alexion Pharmaceuticals, Inc. 19/10/2017

Alexion Pharmaceuticals, Inc. - Close Out Letter 10/19/17


Recipient:
Alexion Pharmaceuticals, Inc.


United States

Issuing Office:

United States


 

  

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Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd FL
Parsippany, NJ 07054
Telephone: (973) 331-4900
FAX: (973) 331-4969 

 
 

October 19, 2017

Via UPS Next Day Air Saver
With Signature Confirmation

Ludwig Hanston, CEO
Alexion Pharmaceuticals, Inc.
100 College Street
New Haven, CT 06511.

Dear Dr. Hanston:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter CMS# 352798 dated March 22, 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.

Sincerely,
/S/

Maya M. Davis
Compliance Officer
Division of Pharmaceutical Quality Operations 1