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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
692-0216918-6/4/1 18-Aug-2009 80FLL 3006098899 Ningbo Wantai Ltd China
 
UPS-1234174-3/59/1 06-Aug-2009 80FMC 3004532785 Shijiazhuang Brilliant Ocean Plastic Co., Ltd. China
 
UPS-1233245-2/5/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/61/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/130/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/133/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/159/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/180/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
UPS-1233245-2/195/1 20-Aug-2009 80FMC 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
FR1-0012640-3/1/1 13-Aug-2009 80FMF 3003528643 Shanghai Kindly Enterprise Group Co. China
 
231-8424490-6/1/1 31-Aug-2009 80FMF 3007000232 Pfizer Clinical Research Unit, Hopital Erasme Belgium
 
T94-0050248-8/12/1 13-Aug-2009 80FMI 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
MH9-0075452-3/1/1 05-Aug-2009 80FMZ 3003307657 Ningbo David Medical Device Co.,Ltd China
 
MH9-0075976-1/1/1 19-Aug-2009 80FNK 3006040530 Hebei Pukang Medical Instruments Co Ltda China
 
T94-0050248-8/28/1 13-Aug-2009 80FOZ 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
T94-0050248-8/29/1 13-Aug-2009 80FOZ 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
605-7050407-0/7/1 28-Aug-2009 80FRL 1000397519 R.I. Weaving Pakistan
 
112-8638652-2/1/1 24-Aug-2009 80FRN 3004265295 Zhejiang Medicines & Health Products Import & Export Co. Ltd China
 
112-7296400-1/1/1 26-Aug-2009 80FRN 3002936294 Curlin Medical Llc United States
 
T94-0050248-8/25/1 13-Aug-2009 80GAZ 3005327291 Shanghai Neo-Medical Import & Export Co., Ltd. China
 
AEK-9756217-3/1/1 21-Aug-2009 80KGX 3007214663 Topway Cargo Co Ltd Hong Kong SAR
 
EQ6-0009737-0/1/1 06-Aug-2009 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0009738-8/1/1 06-Aug-2009 80LDQ 5833 EPPENDORF AG Germany
 
EQ6-0009810-5/1/1 07-Aug-2009 80LDQ 3007356683 Adeor Medical Technologies Gmbh Germany
 
EQ6-0009847-7/1/1 21-Aug-2009 80LDQ 3003675282 Biorad Laboratories Europe Ltd United Kingdom
 
ENE-0000265-8/1/1 31-Aug-2009 80LGX 3007725107 Jiangsu Soho International Group Wuxi Co., Ltd. China
 
N98-1013713-9/1/1 05-Aug-2009 80LYY 3003445671 Hycare International Co., Ltd. Thailand
 
K80-0967352-7/1/1 19-Aug-2009 80LYY 3004360380 Multisafe Sdn. Bhd. Malaysia
 
930-0234894-9/1/1 26-Aug-2009 80LYY 3003921460 PT Wrp Buana Multicorp Indonesia
 
930-0234894-9/1/2 26-Aug-2009 80LYY 3003921460 PT Wrp Buana Multicorp Indonesia
 
DE6-3252897-7/1/1 27-Aug-2009 80LYY 1000184859 Perusahaan Getah Asas SDN BHD Malaysia
 
DE6-3252897-7/2/1 27-Aug-2009 80LYY 1000184859 Perusahaan Getah Asas SDN BHD Malaysia
 
DE6-3252897-7/3/1 27-Aug-2009 80LYY 1000184859 Perusahaan Getah Asas SDN BHD Malaysia
 
K80-0969552-0/1/3 31-Aug-2009 80LYY 1000154564 Shun Thai Rubber Gloves Industry Co., Ltd. (Factory) Thailand
 
525-0768026-3/1/1 04-Aug-2009 80LYZ 3006048101 Tangshan Luxiong Plastic Products Co., Ltd. China
 
692-0217560-5/1/1 06-Aug-2009 80LYZ 3000179240 Seal Polymer Industries Bhd Malaysia
 
692-0217560-5/1/2 06-Aug-2009 80LYZ 3000179240 Seal Polymer Industries Bhd Malaysia
 
BEA-9055675-0/1/1 12-Aug-2009 80LYZ 3006543087 GLORMED COLOMBIA S.A. Colombia
 
E41-0061804-7/1/1 25-Aug-2009 80LYZ 3004532785 Shijiazhuang Brilliant Ocean Plastic Co., Ltd. China
 
525-0768093-3/1/1 06-Aug-2009 80LZA 3005632797 Kossan Latex Industries (M) Sdn Bhd Malaysia
 
112-8602215-0/1/1 20-Aug-2009 80LZA 3003256709 Latexx Manufacturing Sdn Bhd Malaysia
 
BDF-0010533-2/1/1 25-Aug-2009 80LZA 1000152173 Shijiazhuang Hongray Plastic Products Co., Ltd. China
 
BDF-0010533-2/2/1 25-Aug-2009 80LZA 1000152173 Shijiazhuang Hongray Plastic Products Co., Ltd. China
 
FR1-0012785-6/3/1 14-Aug-2009 80MEB 3006471098 Daiken Medical Co. Ltd. Japan
 
AB8-0156302-9/3/1 04-Aug-2009 80MMP 3002896364 Changzhou Primed Medical Products Co., Ltd. China
 
AB8-0156302-9/3/2 04-Aug-2009 80MMP 3002896364 Changzhou Primed Medical Products Co., Ltd. China
 
UPS-5109563-4/1/1/C 20-Aug-2009 80MSN 3007635885 Wywye Industrial Co Ltd China
 
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