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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