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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

 

Importance:     High

 

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.

 

Thank you,

Sonday L Kelly, M.S. 

Regulatory Project Manager 
U.S. Food & Drug Administration 
FDA/ OMPT/ CBER/ OBRR/ DBA/ RPMB 
WOC1; HFM-380 
1401 Rockville Pike 
Rockville, MD  20852 
Direct Ph# 240.507.8446 
Fax# 301.827.2857

Email: sonday.kelly@fda.hhs.gov

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