


Information Request Email, January 11, 2012 - Hyqvia




 

 
From: Maruya, Aiko [Aiko_Maruya@baxter.com]
 Sent: Wednesday, January 11, 2012 4:54 PM
 To: Shields, Mark
 Cc: Blackshere, Angela L
 Subject: RE: STN 125402/0 Information Request

I acknowledge receipt of the attached message. Aiko

From: Shields, Mark [mailto:Mark.Shields@fda.hhs.gov] 
 Sent: Wednesday, January 11, 2012 8:00 AM
 To: Maruya, Aiko
 Cc: Blackshere, Angela L
 Subject: STN 125402/0 Information Request

Dear Ms. Maruya:

Please acknowledge receipt.

We are reviewing your June 30, 2011 biologics license application (BLA) for 
Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase.  We 
determined that the following information on media fill validation and 
sterilization/depyrogenation is necessary to continue our review:

1)  For the Dual Vial Unit Device:
  Please provide details of the current FDA clearance history.
  Please provide the vendor qualification and acceptance criteria including list 
  of any additional in-house testing.
  Please provide the dual vial unit protocol and qualification summary report.  
  We noted that information included under 3.2.P.2.1.3.4 provides only a high 
  level qualification summary and does not include details (such as test date, 
  number of units tested, qualification of different dosage sizes).

2)  Vial/Stopper (b)(4) Washing validation confirmation:

Please provide the most recent ---(b)(4)--- vial washing confirmation validation 
protocol and report for the 2 mL and 20 mL vials, and 13 mm and 20 mm vial 
stoppers.  Please include a detailed discussion and resolution of any deviations 
observed during validation.

3)  Vial Depyrogenation:

Please provide the most recent (b)(4) vial depyrogenation validation protocol 
and report including a discussion and resolution of any deviations observed 
during validation (2 mL, 5 mL and 20 mL vials).

4)  Stopper Sterilization:

Please provide your most recent stopper (b)(4) sterilization requalification 
protocol and summary report including any deviation, investigation and 
corrective action taken (each of ---(b)(4)------ 13 mm, 20 mm stopper and 20 mm 
--------(b)(4)---- stoppers).

5)  Filling equipment Sterilization:

Please provide the maximum worst-case durable load configuration --(b)(4)-- 
sterilization confirmation protocol and report summary including discussion and 
resolution of any deviations observed during validation.

6)  Media fill:

Please provide the most recent media fill (b)(4) requalification 
-------------------------------------------------(b)(4)---------------------------------------------------------------------------i
protocols and the report including a detail discussion and resolution of any 
deviations observed.

The review of this submission is on-going and issues may be added, expanded 
upon, or modified as we continue to review this submission. 

Please submit your response to this information request as an amendment to this 
file by February 1, 2012 referencing the date of this request. If you anticipate 
you will not be able to respond by this date, please contact the Agency 
immediately so a new response date can be identified.

If we determine that your response to this information request constitutes a 
major amendment, we will notify you in writing. 

The action due date for this file is April 29, 2012.

If you have any questions, please contact me at (301) 827-6171.

Sincerely,

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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