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CLOSEOUT LETTER

Sanquin Plasma Products Sep 15, 2016

Sanquin Plasma Products - Close Out Letter 9/15/16


Sanquin Plasma Products

   

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

 
  Food and Drug Administration
Silver Spring MD 20993
 

September 15, 2016

Pieter de Geus, PhD.
Chief Executive Officer
Sanquin Plasma Products
Plesmanlaan 125
1066 CX, Amsterdam, Netherlands

Dear Dr. de Geus:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter [CBER-13-04]. 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/

Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research


cc: Kristin Murray
     Director – Global Regulatory CMC
     Shire Pharmaceuticals
     200 Shire Way
     Lexington, MA