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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
UPS-0908350-7/1/1 10-Sep-2012 80FLE 1000652483 Controles Latinoamericanos Sa De Cv Mexico
 
660-5503116-6/1/1 11-Sep-2012 80FLE 3007123908 APOTHECARIES SUNDRIES MANUFACTURING COMPANY India
 
ARV-3210972-5/3/1 14-Sep-2012 80FLG 3009545344 Fuzhou Desen Preci China
 
ARV-3210972-5/2/1 14-Sep-2012 80FLG 3009545344 Fuzhou Desen Preci China
 
ARV-3210972-5/1/1 14-Sep-2012 80FLG 3009545344 Fuzhou Desen Preci China
 
336-7370455-1/5/1 12-Sep-2012 80KGX 3007335339 Union Chance Co Ltd China
 
336-7370455-1/5/2 12-Sep-2012 80KGX 3007335339 Union Chance Co Ltd China
 
112-8941415-8/1/1 17-Sep-2012 80KMJ 3002841919 Applied Hearing Ltd New Zealand
 
600-7287493-0/1/2 05-Sep-2012 80LDQ 3002867456 GE Medical Systems - General Electric Co. United States
 
TZ6-0127547-0/1/1/A 28-Sep-2012 80LKB 3006851654 Wuxi Medicall lnstrument Factory China
 
TZ6-0127547-0/1/1/B 28-Sep-2012 80LKB 3006851654 Wuxi Medicall lnstrument Factory China
 
TZ6-0127547-0/1/1/C 28-Sep-2012 80LKB 3006851654 Wuxi Medicall lnstrument Factory China
 
TZ6-0127547-0/1/1/D 28-Sep-2012 80LKB 3006851654 Wuxi Medicall lnstrument Factory China
 
K80-1013581-3/1/1 05-Sep-2012 80LYY 3008932202 NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. China
 
K80-1013581-3/1/2 05-Sep-2012 80LYY 3008932202 NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. China
 
K80-1013581-3/1/3 05-Sep-2012 80LYY 3008932202 NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. China
 
K80-1013581-3/1/4 05-Sep-2012 80LYY 3008932202 NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. China
 
K80-1013581-3/1/5 05-Sep-2012 80LYY 3008932202 NINGXIA MARVISUN RUBBER & PLASTIC PRODUCTS CO., LTD. China
 
DE6-3257792-5/3/1 05-Sep-2012 80LYY 3006552561 WEAR SAFE (MALAYSIA) SDN.BHD. Malaysia
 
DE6-3257792-5/2/1 05-Sep-2012 80LYY 3006552561 WEAR SAFE (MALAYSIA) SDN.BHD. Malaysia
 
DE6-3257792-5/1/1 05-Sep-2012 80LYY 3006552561 WEAR SAFE (MALAYSIA) SDN.BHD. Malaysia
 
224-2081740-9/1/1 14-Sep-2012 80LYY 1000153953 Laglove Sdn Bhd (M) aka LA Glove Malaysia
 
WC1-8539645-2/192/1 24-Sep-2012 80LYY 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
442-0776193-1/2/1 27-Sep-2012 80LYY 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
442-0776193-1/3/1 27-Sep-2012 80LYY 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
429-0851338-7/1/1 04-Sep-2012 80LYZ 3009266834 Zibo Yinshilai Textile Co. Ltd China
 
429-0851338-7/1/2 04-Sep-2012 80LYZ 3009266834 Zibo Yinshilai Textile Co. Ltd China
 
429-0851338-7/1/3 04-Sep-2012 80LYZ 3009266834 Zibo Yinshilai Textile Co. Ltd China
 
W69-3254876-2/1/1 12-Sep-2012 80LYZ 3006846833 Langfang Huilong Plastic Product Co., Ltd China
 
862-1037232-1/1/1 18-Sep-2012 80LYZ 3009314982 Wangda Plastic Co Ltd China
 
862-1037232-1/1/2 18-Sep-2012 80LYZ 3009314982 Wangda Plastic Co Ltd China
 
862-1037232-1/1/3 18-Sep-2012 80LYZ 3009314982 Wangda Plastic Co Ltd China
 
DE6-3257565-5/1/1 05-Sep-2012 80LZA 3005099002 Great Glove Sdn Bhd Malaysia
 
DE6-3257565-5/2/1 05-Sep-2012 80LZA 3005099002 Great Glove Sdn Bhd Malaysia
 
DE6-3257716-4/1/1 05-Sep-2012 80LZA 1000153304 Brightway Holdings SDN BHD Malaysia
 
DE6-3257478-1/1/1 10-Sep-2012 80LZA 1000153304 Brightway Holdings SDN BHD Malaysia
 
DE6-3257478-1/2/1 10-Sep-2012 80LZA 1000153304 Brightway Holdings SDN BHD Malaysia
 
BEA-9505807-5/4/1 14-Sep-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
WC1-8538687-5/226/1 27-Sep-2012 80LZA 3005448862 Zhenjiang Heyu Plastic and Rubber Co., Ltd. China
 
442-0776193-1/1/1 27-Sep-2012 80LZA 3002808507 WRP Asia Pacific Sdn Bhd Malaysia
 
DO7-8398746-7/1/1 04-Sep-2012 80LZF 3009696956 Chungwoo Medical Co. Korea, Republic Of (South)
 
DO7-8398730-1/1/1 04-Sep-2012 80MEG 3009690808 Changzhuua Dahua Imp&Exp Co China
 
AEK-0482247-0/1/1 05-Sep-2012 80MQX 3004464549 Taifeng Beauty & Medical Equipment Co Ltd China
 
M76-1830732-8/1/1 06-Sep-2012 80MQX 3005923596 Pierenkemper Gmbh Germany
 
M76-1830736-9/1/1 06-Sep-2012 80MQX 3005923596 Pierenkemper Gmbh Germany
 
UPS-7855324-1/1/1 28-Sep-2012 80MWV 3002926090 RI. MOS S.R.L. Italy
 
BJY-0710313-6/3/1 17-Sep-2012 80MXI 3009685086 BIOMECANICA INDUSTRIA E COMERCIO DE PRODUTOS ORTOPEDICOS Brazil
 
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