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Request for Information Email, January 25, 2012 - SOLX® System




  

 
From:                    Kelly, Sonday
Sent:                      Wednesday, January 25, 2012 11:45 AM
To:                         'Lynn Jensen'
Subject:                 BN110059 - Request for Information

Our Reference:  BN110059

Hemerus Medical LLC
Attention: Ms. Lynn Jensen
January 25, 2012
Sent by email

Dear Ms. Jensen:

We are reviewing your October 28, 2011 new drug application (NDA) for HEMERUS 
LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with 
CPD Anticoagulant and SOLX® Additive.   We determined that the following 
information is necessary to continue our review:

For Hemerus:
  Please provide a Bill of Materials (BOM) for the LeukoSep leukocyte reduction 
  filter.  The BOM should include information on the materials, layers, surface 
  treatment, etc which comprise the filter.  This information was requested by 
  FDA on November 30, 2011, and a response has not been provided.

For JMS Singapore PTE LTD:

2.   Your response received on December 12, 2011 regarding ink and labeling 
issues did not provide sufficient information for FDA to determine the safety 
and integrity of inks used on your blood bag labels.  You or your ink 
manufacturer should provide the following information:

a.   Results from tests demonstrating ink resistance to acid, alcohol or 
nitro-solvents when applied to your label stocks have not been provided. Please 
provide results from ISO 11628 and ISO 2837 or similar methods to demonstrate 
ink resistance and stability using an adequate number of printed labels (FDA 
recommends an n= 3).

b.   The cytotoxic potential of your printed blood bag labels should be 
determined using the MEM elution (e.g., USP <87>) or similar assay.

c.   Please submit Master Files, including the ink formulation and any 
additional stability or test data for the label ribbon in-house print ink and 
any other inks used on your blood bag labels.

d.   Please provide the name and contact information of the printing company who 
will be responsible for applying and polymerizing your inks onto your label 
stocks.

3.    Your ink manufacturer(s) should submit an ink Master File(s) directly to 
FDA/CBER.  Please refer to 
(http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm122886.htm).
or contact FDA directly for more information on the Master File submission 
process.

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 25, 2012 referencing the date of this request.  

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 August 31, 2012.

If you have any questions, please contact me.

Sincerely,
Sonday L Kelly, M.S.  
Regulatory Project Manager 
U.S. Food & Drug Administration 
CBER/ OBRR/ DBA/ RPMB 
WOC1; RM577N; HFM-380 
1401 Rockville Pike 
Rockville, MD  20852 
Direct Ph# 301.827.6122 
Fax# 301.827.2857
Email: sonday.kelly@fda.hhs.gov

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