Information Request Email, February 14, 2014 - ALPROLIX	

From: Huang, Ellen (CBER)
Sent: Friday, February 14, 2014 4:29 PM
To: 'Suzanne Stella'; Denise Schultz
Cc: Thompson, Edward
Subject: RE: Information request BLA 125444 - Visual inspection

Denise

I have one more question for you.
 1. You stated that the transport of filled products to the lyophilizer is performed by placing ----------------------(b)(4)--------------------------------------------. Can you please clarify if the loading onto the -----(b)(4)----- is a manual or automated process?

Thanks,
 Ellen Huang
 Consumer Safety Officer
 FDA/CBER/OCBQ/DMPQ/MRBII
 1401 Rockville Pike, HFM-676
 Rockville, MD 20852
 Phone: 301.827.7199
 Fax: 301.827.3536
 Email: ellen.huang@fda.hhs.gov

From: Suzanne Stella [mailto:suzanne.stella@biogenidec.com] 
 Sent: Thursday, February 13, 2014 7:01 PM 
 To: Huang, Ellen (CBER) 
 Cc: Thompson, Edward; Denise Schultz 
 Subject: Information request BLA 125444 - Visual inspection

Hi Ellen,

Sorry to be so late getting back to you today, but I just got my power back!. I have been informed that we should be able to provide the information regarding the training of individuals for the 100% inspection process at -(b)(4)- by Monday. Denise will be send this along --(b)(6)---------------.

I hope you all stay safe during this storm that is going your way next!

Sue

Suzanne Stella
 Biogen Idec
 Director, Regulatory CMC
 5000 Davis Drive
 Research Triangle Park, NC 27709
 P: 919-993-1121
 C:----(b)(6)----
