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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:
- 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.
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
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