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From: Amin, Pankaj (Pete)
Sent: Tuesday, September 13, 2011 11:02 AM
To: Cordaro, Debbie
Cc: Syin, Chiang
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

Hi Debbie,

This is copy from Baxter BLA:
"Baxter BLA #125402, cross-referenced the DMF (b)(4) and DMF (b)(4) filed by 
Baxter -----------(b)(4)-------------------, which provides the facility and 
equipment details for the rHuPH20 component."

Baxter should not cross reference DMF, but file all the required information as 
stand alone (part of BLA) as per our CMC guidance documents.  This is CBER 
policy and we should enforce it.

Thanks
Pete


From: Cordaro, Debbie  
Sent: Tuesday, September 13, 2011 10:54 AM
To: Amin, Pankaj (Pete)
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

Hi Pete,

CBER IRA (b)(4) is an IND OCTGT file 
for-------------------(b)(4)---------------------------------------- was an IND 
from OTRR ( that was transferred to CDER) for 
------------------------------(b)(4)----------------------            
------------------------------------(b)(4)--------------------------------------------------------------------.

I doubt theseDMF numbers are part of these INDs.  What do you think? Are they 
CDR files, perhaps?

Debbie

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR 
Voice: 301-827-6157 
debbie.cordaro@fda.hhs.gov


From: Amin, Pankaj (Pete)  
Sent: Monday, September 12, 2011 2:35 PM
To: Cordaro, Debbie
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

HI Debbie,

Thanks, 

this Baxter BLA cited (cross reference) DMF # (b)(4) and DMF (b)(4) (facility 
and equipment details). I need copies of review memo for these DMF files or copy 
of  DMF.  Can you help me locate these?

Thanks
Pete


From: Cordaro, Debbie  
Sent: Monday, September 12, 2011 2:29 PM
To: Amin, Pankaj (Pete)
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

Hi Pete,

I am covering for Mark, who took over for Kelly on this file (never good to be 
the 3rd RPM) and did some digging.  It appears the Filing letter also was 
designated as the NDI (No deficiencies Identified) letter, so the milestone was 
met.  That being said, I will send your issue as an IR to the firm ASAP.

Debbie

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR 
Voice: 301-827-6157 
debbie.cordaro@fda.hhs.gov


From: Amin, Pankaj (Pete)  
Sent: Monday, September 12, 2011 11:59 AM
To: Cordaro, Debbie
Cc: Renshaw, Carolyn; Trout, Deborah; Scott, Dorothy; Reed, Daria; Syin, Chiang
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

Draft letter ready comment:

Please provide information on all sterilization and aseptic processes as 
described in the “Guidance for Industry for the Submission of Documentation for 
Sterilization Process Validation in Application for Human and Veterinary Drug 
products.”

Thanks
Pete


From: Cordaro, Debbie  
Sent: Monday, September 12, 2011 9:01 AM
To: Amin, Pankaj (Pete)
Cc: Renshaw, Carolyn; Trout, Deborah; Scott, Dorothy; Reed, Daria
Subject: RE: 125402/0  Deficiencies Identified due date is 
12-Sep-2011--TODAY---sent issues by Noon

Hi Pete,

The Deficiencies Identified Letter is due Today. If you have issues for this 
letter, please send me the letter ready comments by noon today so I can 
circulate the letter.

Thank you,
Debbie

Debbie Cordaro
Regulatory Project Manager
FDA/CBER/OBRR 
Voice: 301-827-6157 
debbie.cordaro@fda.hhs.gov


From: Amin, Pankaj (Pete)  
Sent: Friday, September 09, 2011 4:57 PM
To: Kannan, Bhanu; Shields, Mark; Scott, Dorothy; Yang, Ling; Reed, Jennifer; 
Struble, Evi; Mahmood, Iftekhar; Cheng, Chunrong; Popat, Alpita; Chambers, Wiley 
A; Campbell, Karen M
Cc: Cordaro, Debbie; Valencia, Iliana; Malla, Amy; Syin, Chiang; Michaelis, 
Marion
Subject: RE: 125402/0  Deficiencies Identified due date is 12-Sep-2011

I was not able to find some of the important information for equipment/container 
closure sterilization, media fill, depyrogenation, and some additional  facility 
related items (It appears that Baxter chosen to cross- reference DMF for the 
Baxter (b)(4) facility as a result these information are missing from the BLA, 
Baxter should provide this information as part of BLA).

Baxter has submitted inspection history for all three facilities, based on this 
information we may recommend to waive the facility inspection (pending 
compliance check confirmation).

Will request missing items from Baxter through RPM.

Thanks
Pete Amin


From: Kannan, Bhanu  
Sent: Wednesday, September 07, 2011 2:44 PM
To: Shields, Mark; Scott, Dorothy; Yang, Ling; Reed, Jennifer; Struble, Evi; 
Mahmood, Iftekhar; Cheng, Chunrong; Amin, Pankaj (Pete); Popat, Alpita; 
Chambers, Wiley A; Campbell, Karen M
Cc: Cordaro, Debbie; Valencia, Iliana; Malla, Amy
Subject: RE: 125402/0  Deficiencies Identified due date is 12-Sep-2011

No issues.
Bhanu


From: Shields, Mark  
Sent: Tuesday, September 06, 2011 2:09 PM
To: Scott, Dorothy; Yang, Ling; Reed, Jennifer; Struble, Evi; Mahmood, Iftekhar; 
Cheng, Chunrong; Amin, Pankaj (Pete); Kannan, Bhanu; Popat, Alpita; Shields, 
Mark; Chambers, Wiley A; Campbell, Karen M
Cc: Cordaro, Debbie; Valencia, Iliana; Malla, Amy
Subject: 125402/0  Deficiencies Identified due date is 12-Sep-2011

Hi All,

This original submission from Baxter for Immune Globulin Infusion (Human), 10% 
with Recombinant Human Hyaluronidase has a Deficiencies Identified due date of 
12-Sep-2011.

Do we have issues for a letter?

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

 
 

    
 

  