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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 86-Ophthalmic


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
799-1002751-9/1/1 13-Jan-2014 86HKY 3010275082 Ajanta Export Industries India
 
T94-0061010-9/6/1 29-Jan-2014 86HMG 3003525532 Ellex Medical Pty Ltd Australia
 
T94-0061010-9/3/1 29-Jan-2014 86HMG 3003525532 Ellex Medical Pty Ltd Australia
 
315-3218959-9/11/1 28-Jan-2014 86HOI 3003206030 Dfass Jamaica Limited Jamaica
 
315-3218959-9/13/1 28-Jan-2014 86HOI 3003206030 Dfass Jamaica Limited Jamaica
 
UPS-3633827-7/1/1 14-Jan-2014 86HPX 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
799-2509524-6/1/1 08-Jan-2014 86HQD 3010584998 Johnons@Johnson China
 
AEK-1707952-2/1/1 28-Jan-2014 86HQD 3010465735 Getlenses United Kingdom
 
T94-0061010-9/1/1 29-Jan-2014 86HQF 3003525532 Ellex Medical Pty Ltd Australia
 
T94-0061010-9/5/1 29-Jan-2014 86HQF 3003525532 Ellex Medical Pty Ltd Australia
 
T94-0061010-9/2/1 29-Jan-2014 86HQF 3003525532 Ellex Medical Pty Ltd Australia
 
BGX-1119709-8/1/1 02-Jan-2014 86HQY 3002719961 Marcolin S.p.A. Italy
 
799-1548830-2/1/1 03-Jan-2014 86HQY 3010459246 Rui Rui Leopard Bicycle Accessor China
 
799-0837382-6/1/1 03-Jan-2014 86HQY 3009549392 Linhai Tianma Glasses Factory China
 
UPS-2035228-4/1/3 07-Jan-2014 86HQY 1000265335 Sun Hing Optical Manufactory Ltd. Hong Kong SAR
 
UPS-2035228-4/1/2 07-Jan-2014 86HQY 3003331633 Arts Optical Manufactory, Liimited China
 
UPS-2035228-4/1/1 07-Jan-2014 86HQY 3003117010 Argent Optical Manufactory Limited China
 
AYF-0061193-5/46/1 07-Jan-2014 86HQY 3010212737 Goertz-Welsch Modedesign Gmbh Germany
 
605-2067937-8/1/1 07-Jan-2014 86HQY 3009751629 Idt Srl C/O Dhl Italy
 
AEK-0814136-4/1/1 07-Jan-2014 86HQY 3009536856 Brioni Spa Italy
 
AEK-0814150-5/1/1 07-Jan-2014 86HQY 3007903237 Brioni Roman Style Spa Italy
 
AEK-0817048-8/1/1 09-Jan-2014 86HQY 3010479809 Sanwa Iron Works Co.Ltd Japan
 
799-1815650-0/1/1 10-Jan-2014 86HQY 3010490534 G&D Optical Industry Co Ltd China
 
315-3218133-1/1/1 10-Jan-2014 86HQY 3010547976 Artsun Industrial Co Hong Kong SAR
 
799-2068658-5/1/1/A 10-Jan-2014 86HQY 3010533505 See-Good Enterprise Co., Ltd China
 
799-2068658-5/1/1/B 10-Jan-2014 86HQY 3010533505 See-Good Enterprise Co., Ltd China
 
799-2068658-5/1/1/C 10-Jan-2014 86HQY 3010533505 See-Good Enterprise Co., Ltd China
 
799-2068658-5/1/1/D 10-Jan-2014 86HQY 3010533505 See-Good Enterprise Co., Ltd China
 
799-2068658-5/1/1/E 10-Jan-2014 86HQY 3010533505 See-Good Enterprise Co., Ltd China
 
EQN-0011255-0/25/1 17-Jan-2014 86HQY 3010598888 Mad In China Trading Co., Limited China
 
DO7-8306731-0/1/1 17-Jan-2014 86HQY 3010514999 ocean sunglasses Taiwan
 
799-1859027-8/1/1 22-Jan-2014 86HQY 3009549392 Linhai Tianma Glasses Factory China
 
AEK-0817594-1/1/1 27-Jan-2014 86HQY 3010483775 Guangzhou J&T Glasses China
 
EQP-0007009-5/1/1 28-Jan-2014 86HQY 3003499479 Wenzhou M & C Foreign Trade Co., Ltd. China
 
AWM-0023812-3/2/1 28-Jan-2014 86HQY 3008227811 Brands Oi Spa Italy
 
315-3218959-9/10/1 28-Jan-2014 86HQY 3003206030 Dfass Jamaica Limited Jamaica
 
315-3218959-9/12/1 28-Jan-2014 86HQY 3003206030 Dfass Jamaica Limited Jamaica
 
315-3218959-9/14/1 28-Jan-2014 86HQY 3003206030 Dfass Jamaica Limited Jamaica
 
AM1-0190301-2/1/1 31-Jan-2014 86HQY 3009234067 More In Sunglasses Company China
 
JF7-0109427-4/2/1 31-Jan-2014 86HQY 3002851271 Luxottica Group Spa Italy
 
AZE-0063416-7/1/1 07-Jan-2014 86HQZ 3008237469 Sam Yung Trading Korea, Republic Of (South)
 
AEK-3512732-9/1/1 09-Jan-2014 86HQZ 3004110900 Oxibis Exalto SAS France
 
799-2146414-9/1/1 10-Jan-2014 86HQZ 3010144798 Undostrial France
 
WGB-1312064-4/1/1 10-Jan-2014 86HQZ 3004530394 Hang Fai Optical Industrial Co Hong Kong SAR
 
799-1729729-7/1/1 13-Jan-2014 86HQZ 3004104691 Zettner Brillenfavrikation Germany
 
799-1729729-7/2/2 13-Jan-2014 86HQZ 1000401936 Hamamoto Technical Co., Ltd. Japan
 
799-1729729-7/2/1 13-Jan-2014 86HQZ 1000401936 Hamamoto Technical Co., Ltd. Japan
 
WGB-1311133-8/1/1 15-Jan-2014 86HQZ 3003805077 Xiamen Ever Young Hi-Tech Optical Co., Ltd. China
 
WGB-1311133-8/2/1 15-Jan-2014 86HQZ 3003805077 Xiamen Ever Young Hi-Tech Optical Co., Ltd. China
 
EQN-0011255-0/26/1 17-Jan-2014 86HQZ 3010598888 Mad In China Trading Co., Limited China
 
AEK-4519948-2/1/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AEK-4519948-2/2/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AEK-4521201-2/2/1 17-Jan-2014 86HQZ 3010585998 Beausoleil France
 
AEK-4521201-2/1/1 17-Jan-2014 86HQZ 3010585998 Beausoleil France
 
AEK-4519884-9/1/1 17-Jan-2014 86HQZ 3010585998 Beausoleil France
 
AEK-4519951-6/2/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AEK-4519951-6/1/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AEK-4519706-4/2/1 17-Jan-2014 86HQZ 3005974834 Frederic Beausoleil France
 
AEK-4519706-4/1/1 17-Jan-2014 86HQZ 3005974834 Frederic Beausoleil France
 
AEK-4519949-0/2/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AEK-4519949-0/1/1 17-Jan-2014 86HQZ 3005496415 Beausoleil France
 
AZE-0064811-8/1/1 23-Jan-2014 86HQZ 3008237469 Sam Yung Trading Korea, Republic Of (South)
 
AWM-0023812-3/1/1 28-Jan-2014 86HQZ 3008227811 Brands Oi Spa Italy
 
AEK-4524760-4/1/1 30-Jan-2014 86HQZ 3010031483 Wenzhou Robo Import & Export Co., Ltd. China
 
JF7-0109427-4/1/1 31-Jan-2014 86HQZ 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
799-1618771-3/1/1 03-Jan-2014 86LPL 3010535464 Meralens GmbH Germany
 
799-1069421-9/1/1 10-Jan-2014 86LPL 3008070629 Maxvue Vision Sdn Bhd Malaysia
 
UPS-3266749-7/1/1 16-Jan-2014 86LPL 3010546190 Claudio Assirelli Italy
 
799-1030301-9/1/1 22-Jan-2014 86LPL 3002806704 Ciba Vision GmbH Germany
 
M92-0912371-7/9/1 24-Jan-2014 86LPL 1000386802 Tana Cosmetics Manoa Germany
 
M92-0912371-7/9/2 24-Jan-2014 86LPL 1000386802 Tana Cosmetics Manoa Germany
 
AEK-4534081-3/1/1 27-Jan-2014 86LPL 3010445156 Getlenses Bv Netherlands
 
799-2234860-6/1/1 03-Jan-2014 86MVN 3010223015 Falco Linsen Ag Switzerland
 
799-1684125-1/1/1 03-Jan-2014 86MVN 3008034930 Vassen Co Ltd Korea, Republic Of (South)
 
799-2491680-6/1/1 06-Jan-2014 86MVN 1000222023 Johnson & Johnson Vision Care, Inc. United States
 
799-2170010-4/1/1 09-Jan-2014 86MVN 3009541900 Guangzhou Winis Trade Co Ltd China
 
T94-0061010-9/4/1 29-Jan-2014 86NFF 3003525532 Ellex Medical Pty Ltd Australia
 
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