


Information Request Email, August 2, 2011 - Hyqvia




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From: Lewis, Kelly R
Sent: Tuesday, August 02, 2011 10:24 AM
To: 'Maruya, Aiko'
Cc:  Blackshere, Angela L
Subject: 125402/0  Baxter Immune Globulin Infusion (Human), 10% with Recombinant 
Human Hyaluronidase, Original BLA - Information Request

Hi Aiko,

This email conveys our request for additional information regarding your 
submission for STN 125402/0 that was submitted to the agency on June 30, 2011, 
as an Original Biologics License Application for Immune Globulin Infusion  
(Human), 10% with Recombinant Human Hyaluronidase.  Please respond as soon as 
possible.

Information request questions for facility inspection:

1.   Please provides FDA inspection history (date of inspection, investigator 
name), copy of FDA-483 and list of any regulatory actions for the 
-------------(b)(4)-------------------------        
-------------------------------------------------------------------------------------------------------and 
Baxter Lessines, Belgium (labeling and packaging) facilities.

2.   Please provides following information for the Baxter 
--------------------(b)(4)--------------          
--------------------------------
  Please identify the facility (building and critical process area or room, 
  critical areas room classifications) where critical steps will be performed.
  Please provide list of critical change made to facility, equipment, key raw 
  materials, and qualified vendors used during process validation and identify 
  any changes made since last inspection/process validation. 
  Please provide list of any changes to key critical raw material, API or 
  vendors since process validation.
  List of multi-product/dedicated areas/equipment that will be used for this 
  product.
  Please describe if any new or specialized equipment/areas will be use for this 
  product (other than already license product/equipment for other products).

Please reply to confirm receipt of this information request.

Thanks,
Kelly

Kelly Lewis, MS, MBA
Regulatory Project Manager
Food and Drug Administration
Center for Biologics Evaluation and Research
Phone: 301.827.9427
Fax: 301.827.2857
email: kelly.lewis@fda.hhs.gov

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