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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
FR1-0015085-8/1/1 13-Jun-2013 80BRZ 3005669815 Amsino Medical (Kunshan) Co., Ltd. China
 
FR1-0015081-7/1/1 25-Jun-2013 80FLK 3008303451 SHANGHAIHUACHEN MEDICAL INSTRUMENTS CO., LTD China
 
AEK-1132016-1/1/1 20-Jun-2013 80FLL 3007111320 Shenzhen Changbaoyuan Import And Export Co.,Ltd China
 
FR1-0015033-8/1/1 03-Jun-2013 80FOZ 3004070915 Hanako Medical Japan
 
M50-0295721-0/1/1 21-Jun-2013 80FPO 3000134760 Techlem Medical Corporation Canada
 
UPS-1286120-1/1/1 28-Jun-2013 80FQM 3008368443 Spidertech Inc Canada
 
667-0206048-5/5/1 13-Jun-2013 80FQZ 3010008764 Yangzhou Brushmann (Group) Co., Ltd. China
 
FR1-0015001-5/3/1 03-Jun-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd Japan
 
EBS-0576421-1/1/1 20-Jun-2013 80FRN 3002999813 Hospira Costa Rica Ltda Costa Rica
 
AEK-9178815-4/1/1 06-Jun-2013 80LDQ 3010203143 P&G Beauty And Health China
 
AEK-9178813-9/1/1 06-Jun-2013 80LDQ 3010203143 P&G Beauty And Health China
 
UPS-1354766-8/1/1 28-Jun-2013 80LDQ 3010241145 Li Xi China
 
231-1269879-4/1/1 26-Jun-2013 80LYY 3003514352 Lalan Gloves (Pvt) Ltd. Sri Lanka
 
231-1269879-4/1/2 26-Jun-2013 80LYY 3003514352 Lalan Gloves (Pvt) Ltd. Sri Lanka
 
231-1269879-4/1/3 26-Jun-2013 80LYY 3003514352 Lalan Gloves (Pvt) Ltd. Sri Lanka
 
231-1269879-4/1/4 26-Jun-2013 80LYY 3003514352 Lalan Gloves (Pvt) Ltd. Sri Lanka
 
9M3-1005595-2/1/3 07-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
9M3-1005595-2/4/3 07-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
9M3-1005595-2/2/3 07-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
9M3-1005595-2/3/3 07-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
420-1002848-0/1/1 18-Jun-2013 80LYZ 3009758390 Zibo Tengyue Plastic Products Co., Ltd. China
 
820-4552182-8/1/1 20-Jun-2013 80LYZ 3009758390 Zibo Tengyue Plastic Products Co., Ltd. China
 
9M3-1006241-2/54/2 25-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
9M3-1006302-2/3/2 27-Jun-2013 80LYZ 3006534695 Jiangsu Cureguard Glove Co., Ltd. China
 
UPS-0894182-7/1/2 11-Jun-2013 80MWV 3010188082 Soluciones Logisticas Honduras
 
UPS-1185261-5/2/1 25-Jun-2013 80MWV 3010237703 Trans Sources Intl Ltd Hong Kong SAR
 
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