


Facility Information Request Email, July 12, 2012 - Hyqvia


 
From: Shields, Mark
 Sent: Thursday, July 12, 2012 1:11 PM
 To: Maruya, Aiko
 Cc: 'Blackshere, Angela L'
 Subject: Facility Information request for 125402/0


Hi Aiko,

Here are the six facilities you have listed on the original 356h for 125402/0, 

1. Can you please identify what manufacturing activates happen at each facility?

2. Can you provide either an FEI number or a CFN number for the last two 
facilities?

3. Please confirm these are the only facilities involved with production of 
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase. 
  ----------------------------(b)(4)------------------------------ 
  Baxter S.A., Boulevard Rene Branquart 80, B-7560 Lessines Belgium (CFN # 
  9611642);
  ----------------------------(b)(4)--------------------------------------------------------o

  ----------------------------(b)(4)----------------------------------------------------------------------------n
  ); 
  ---------------------------(b)(4)-----------------------------------------------y

  ---------------------------(b)(4)-----------------------

Thanks!

Mark A. Shields, RAC 
 Regulatory Project Manager 
 HFM-380 FDA/CBER 
 Office of Blood Research and Review 
 Division of Blood Applications
 301-827-6173 fax 301-827-2405 
 email: mark.shields@fda.hhs.gov
 1401 Rockville Pike 
 Rockville, MD 20852-1448 

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