From: Daizadeh, [Iraj iraj_daizadeh@baxter.com]
Sent: Monday, January 27, 2014 3:14 PM
To: Maruna, Thomas
Cc: Walton, Beth; Lemieux, Linda
Subject: BLA 125512/0 - Response to FDA information request: RE: Clarification
from Today's Telecon - January 24, 2013 - Inspection Discussion - Follow up
Attachments: OBI-1 125512-0 Response 27 Jan 2014 to FDA 24 Jan 2014.pdf
Importance: High
Date of Response: 27 January 2014
Attention: Lt. Thomas Maruna, MLS (ASCP)CM
Regulatory Project Management Branch
Division of Blood Applications
Biologics License Application 125512/0
Antihemophilic Factor (Recombinant), Porcine Sequence (OBI-1)
Information request concerning Inspection at Baxter ----(b)(4)---------------- 
Dear Ms. Walton and Lt. Maruna:
Baxter Healthcare Corporation (Baxter) is submitting this response per your information request dated 24 January 2014. The response is attached to this email in PDF format.
Should you have any questions, please contact me at (805) 372-4934 or iraj_daizadeh@baxter.com. The secondary contact is Linda Lemieux, MS, Associate Director, Global Regulatory Affairs, who can be reached at (508) 282-5698 or linda_lemieux@baxter.com. All fax correspondence should be sent to (805) 372-3042.
Sincerely, 
Iraj Daizadeh, PhD
Iraj Daizadeh, PhD | Regulatory Affairs | p:805-372-4934 / f:805-372-3052 | iraj_daizadeh@baxter.com
Mail Box Number: 1A-3, One Baxter Way, Westlake Village, CA 91362
The information transmitted is intended only for the person or entity to which it is addressed and may contain confidential and/or privileged material. Any review, re-transmission, dissemination or other use of, or taking of any action in reliance upon, this information by persons or entities other than the intended recipient is prohibited. If you received this in error, please contact the sender and delete the content.
From: Walton, Beth [mailto:Beth.Walton@fda.hhs.gov] 
Sent: Friday, January 24, 2014 9:01 AM 
To: Daizadeh, Iraj 
Subject: Clarification from Today's Telecon - January 24, 2013 - Inspection Discussion - Follow up 
Iraj:
As a follow up to our call, please confirm the following information discussed at our telecom on January 24, 2014 at 11:00 a.m., 
1. Please confirm the manufacturing processes during the following timeframes. 
For (b)(4)--:
Week of --(b)(4)--
Week of --(b)(4)--
For (b)(4): 
-----(b)(4)----- 
2. Please clarify the type of “mock runs” that can take place during the above timeframes? Which products can be used for the mock run? 

3. Please identify a contact person for each site to assist with travel arrangements for each site? 

4. Please confirm the current FEI for the (b)(4)-- site as ----(b)(4)--------------. Please confirm the Previous FEI.

5. Please confirm which products are currently manufactured at both the (b)(4)-- and (b)(4) sites? 

6. Please provide production schedule for -----(b)(4)------ for both sites and the manufacturing processes that will occur during this timeframe? 

7. Please confirm the names of the “responsible person(s)” for both the (b)(4) and (b)(4) sites ( a contact person for 482 and 483)?
Thank you in advance.
Beth Walton MBA, PMP, RAC 
Regulatory Project Manager 
HFM-380 FDA/CBER 
Office of Blood Research and Review 
Division of Blood Applications 
Office: 301-827-3762 Fax 301-827-2857
Blackberry: 240-994-8675 
Email: beth.walton@fda.hhs.gov 
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