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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 80-General Hospital/Personal Use


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
FR1-0012921-7/1/1 08-Dec-2009 80BRZ 3003279193 Amsino Medical Instrument Co Ltd China
 
E7L-0903556-6/3/1 21-Dec-2009 80FLK 3006681542 Shanghai Sofine International Trade Co., Ltd. China
 
112-9951113-2/1/1 30-Dec-2009 80FLK 3007577668 Yangzhou Shuguang Toothbrushe Ma China
 
112-9509757-3/2/1 16-Dec-2009 80FMC 3007911843 Jcinmed Ltd Taiwan
 
FR1-0013021-5/1/1 01-Dec-2009 80FMF 3003528643 Shanghai Kindly Enterprise Group Co. China
 
AEK-8028641-8/1/1 02-Dec-2009 80FOZ 3007999701 Judith Clute United Kingdom
 
DO7-8360750-3/1/1 11-Dec-2009 80FQL 3004125196 Wandy Rubber Industrial Co Taiwan
 
DO7-8360750-3/2/1 11-Dec-2009 80FQL 3004125196 Wandy Rubber Industrial Co Taiwan
 
336-3802731-1/2/1 15-Dec-2009 80FRN 3007901887 Carboline Uk United Kingdom
 
336-3802731-1/1/1 15-Dec-2009 80FRN 3007901887 Carboline Uk United Kingdom
 
EL3-0016512-2/1/1/B 08-Dec-2009 80LDQ 3006555617 BEIJING SINCOHEREN SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD China
 
AEK-8025563-7/1/1 23-Dec-2009 80LDQ 3007991701 Cool Sense Israel
 
E41-0062529-9/1/1 02-Dec-2009 80LYY 3000179240 Seal Polymer Industries Bhd Malaysia
 
660-2503455-5/1/1 09-Dec-2009 80LYY 3000983331 P.T. Latexindo Tobaperkasa Indonesia
 
F23-9016465-5/1/1 07-Dec-2009 80LYZ 3007362692 TANGSHAN LINYUAN PLASTIC PRODUCTS CO LTD China
 
F23-9017326-8/1/1 07-Dec-2009 80LYZ 3006538626 WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. China
 
BSA-0002761-8/1/1 07-Dec-2009 80LYZ 3006538626 WUXI SHENZHOU PLASTIC PRODUCTS CO., LTD. China
 
TJE-0910070-2/1/1 22-Dec-2009 80LYZ 3007658484 Zibo Wanci Plastic and Rubber Company, LTD China
 
FR1-0012910-0/2/1 08-Dec-2009 80MEB 3006471098 Daiken Medical Co. Ltd. Japan
 
FR1-0012966-2/1/1 05-Dec-2009 80MIA 3002807725 Nipro Medical Industries, Ltd. Japan
 
300-4420912-8/1/1 15-Dec-2009 80MMS 3007640015 Draxis Specialty Pharmaceuticals Inc Canada
 
112-5071274-6/2/1/A 18-Dec-2009 80MSN 3008032868 Shenzhen Kemeier T China
 
112-5071274-6/2/1/B 18-Dec-2009 80MSN 3008032868 Shenzhen Kemeier T China
 
112-9572692-4/1/1 21-Dec-2009 80MSN 3007920209 Changning Dekang Biotechnology C Puerto Rico
 
XXX-0169100-6/2/1 22-Dec-2009 80NKN 3004527568 Pharma Internacional Honduras
 
FD6-3073394-3/1/1 11-Dec-2009 80NPC 3007583547 QUANTUM CO., LTD. China
 
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