Information Request Email, July 12, 2012 - SOLX® System
From: Kelly, Sonday
Sent: Thursday, July 12, 2012 10:20 AM
To: Lynn Jensen
Subject: BN110059; Information Request; Please respond by July 23, 2012
Dear Ms. Jensen:
We are reviewing your October 28, 2011 new drug application (NDA) for LEUKOSEP® HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX® Additive.
We have determined that the following information is necessary to continue our review related to Manufacturing and Product Quality. Please respond to the items below no later than July 23, 2012.
1. In LAB/VP/044/06 you evaluated the bioburden test method for Hemerus SOLX filter system. Please provide the recovery rate and correction factor calculated from this study. Please clarify if the correction factor was used in the test results provided in the revalidation report VP/031/LAB/09.
2. You stated that all organisms found in the JMS facility during environmental monitoring were not heat resistant to ------(b)(4)-----------------. Please provide the data for all organisms tested.
Sonday L Kelly, M.S.
Regulatory Project Manager
U.S. Food & Drug Administration
FDA/ OMPT/ CBER/ OBRR/ DBA/ RPMB
1401 Rockville Pike
Rockville, MD 20852
Direct Ph# 240.507.8446
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