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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
FR1-0014886-0/1/1 05-Mar-2013 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
FR1-0014910-8/1/1 28-Mar-2013 80FPK 3005137998 Nipro (Sha) Co., Ltd China
 
597-0171165-3/6/1 15-Mar-2013 80FQM 3005915537 Umo International Co Ltd Taiwan
 
FR1-0014894-4/3/1 05-Mar-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0014901-7/3/1 29-Mar-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
112-0423987-1/1/1 29-Mar-2013 80FRN 3002999813 Hospira Costa Rica Ltda Costa Rica
 
112-1862909-1/1/1 19-Mar-2013 80KDP 3004966675 Amvex Corporation Canada
 
112-1862909-1/2/1 19-Mar-2013 80KDP 3004966675 Amvex Corporation Canada
 
112-1862909-1/3/1 19-Mar-2013 80KDP 3004966675 Amvex Corporation Canada
 
MH9-2008839-9/1/1 19-Mar-2013 80KMH 3007138511 Shandong Xinhua Medical Instrument Co Ltd China
 
AL6-0056259-2/1/1 15-Mar-2013 80KMI 3004149774 SenTec AG Switzerland
 
AEK-0290715-8/1/1 04-Mar-2013 80KZH 3009818145 Carlos Eduardo Ferreira Brazil
 
002-1190668-0/1/1 28-Mar-2013 80LDQ 3008301410 Ndi Europe Gmbh Germany
 
349-0942378-1/2/2 12-Mar-2013 80LYY 3003958472 Pt. Shamrock Manufacturing Corp. Indonesia
 
349-0942378-1/2/1 12-Mar-2013 80LYY 3003958472 Pt. Shamrock Manufacturing Corp. Indonesia
 
231-6111546-8/1/1 05-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6111546-8/1/2 05-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6111546-8/1/3 05-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6111546-8/1/4 05-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6108698-2/1/1 06-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6108698-2/1/2 06-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6108698-2/1/3 06-Mar-2013 80LYZ 3008177918 Tangshan Kangyuan Glove Co Ltd China
 
231-6111541-9/1/1 07-Mar-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
231-6111541-9/1/2 07-Mar-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
231-6111541-9/1/3 07-Mar-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
231-6111541-9/1/4 07-Mar-2013 80LYZ 3006540060 ZIBO HENGDE PLASTIC & RUBBER PRODUCTS CO., LTD. China
 
231-4391915-1/1/1 29-Mar-2013 80LYZ 3008388225 Tangshan Jiaxing P Lastic Products Co Ltd China
 
231-4391915-1/1/2 29-Mar-2013 80LYZ 3008388225 Tangshan Jiaxing P Lastic Products Co Ltd China
 
231-4391915-1/1/3 29-Mar-2013 80LYZ 3008388225 Tangshan Jiaxing P Lastic Products Co Ltd China
 
442-0798065-5/1/1 13-Mar-2013 80LZA 3008754676 PROFIT POINT SDN BHD Malaysia
 
442-0798065-5/1/2 13-Mar-2013 80LZA 3008754676 PROFIT POINT SDN BHD Malaysia
 
AEK-0787805-7/1/1 21-Mar-2013 80MEG 3002806753 Commonwealth Serum Laboratories (CSL), Ltd. Australia
 
J50-0135004-8/5/1/G 04-Mar-2013 80MWV 3003179406 Domingo Bautista Guatemala
 
442-2275953-0/1/1 19-Mar-2013 80NZJ 3005791274 Firma Dinamika Llc. Co. Russia
 
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