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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Actions by FDA as Recorded in OASIS

for 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0012838-3/1/1 11-Sep-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012841-7/2/1 14-Sep-2009 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0012849-0/1/1 14-Sep-2009 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0012849-0/2/1 14-Sep-2009 78FKP 3002808905 Nikkiso Co., Ltd. (Headquarters) Japan
 
FR1-0012849-0/3/1 14-Sep-2009 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
JF7-0075150-2/1/1 23-Sep-2009 78GCF 3006680097 THD SpA Italy
 
DO7-8216668-3/1/1 15-Sep-2009 78GCQ 3007793295 Sunrise Japan
 
UPS-5571543-5/1/1 18-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5483045-8/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5487252-6/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5486908-4/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5476215-6/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5496985-0/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5495590-9/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5487165-0/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5486098-4/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5484150-5/1/1 22-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5523013-8/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5524428-7/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5523024-5/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522999-9/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522954-4/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5523033-6/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5523027-8/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522915-5/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522850-4/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522777-9/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5524194-5/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522857-9/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522867-8/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522819-9/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522784-5/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
UPS-5522803-3/1/1 23-Sep-2009 78LKY 3006891323 X4 Labs Inc. Canada
 
112-8684837-2/1/1 14-Sep-2009 78MRE 3005236933 Shanghai Qisheng Biological Prep China
 
112-8964152-7/1/1 30-Sep-2009 78NLU 3005897742 Shinjuku Monolith Japan
 
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