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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
315-8161832-4/8/1 25-Jun-2013 86HJO 1000206694 Nidek Co., Ltd. Japan
 
315-8161832-4/2/1 25-Jun-2013 86HKI 1000206694 Nidek Co., Ltd. Japan
 
112-2982045-7/1/1 21-Jun-2013 86HKN 3010142713 Shenzhen Zhongsen Environmental China
 
112-3179772-7/1/1 19-Jun-2013 86HKX 3001022138 Optilasa SA Spain
 
315-8161832-4/1/1 25-Jun-2013 86HMC 1000206694 Nidek Co., Ltd. Japan
 
315-8161832-4/4/1 25-Jun-2013 86HNO 1000206694 Nidek Co., Ltd. Japan
 
112-2726347-8/1/1 04-Jun-2013 86HNR 3006244635 Tulip Surgicals India
 
BNW-0134139-6/10/1 28-Jun-2013 86HOI 3005715538 Duty Free Air And Ship Supply Co United States
 
315-8161832-4/6/1 25-Jun-2013 86HOS 1000206694 Nidek Co., Ltd. Japan
 
315-8161832-4/7/1 25-Jun-2013 86HOS 1000206694 Nidek Co., Ltd. Japan
 
UPS-1703778-2/1/1 14-Jun-2013 86HQG 3009576273 Creative International Concepts Hong Kong SAR
 
MY1-0952228-3/1/1 03-Jun-2013 86HQY 3008904253 Ever Eyewear Co., Ltd. China
 
MY1-0955613-3/1/1 04-Jun-2013 86HQY 3009539131 Ouhai Longfeng Glasses Factory China
 
MY1-0955613-3/1/2 04-Jun-2013 86HQY 3009539131 Ouhai Longfeng Glasses Factory China
 
MY1-0955613-3/1/3 04-Jun-2013 86HQY 3009539131 Ouhai Longfeng Glasses Factory China
 
081-0199396-5/51/1 05-Jun-2013 86HQY 3010202838 Eurochina International Trade Limited China
 
004-6580874-9/58/1 06-Jun-2013 86HQY 3003953571 Ocean Eyewear Hk Hong Kong SAR
 
MD8-0038574-0/1/1 10-Jun-2013 86HQY 3007109690 WENZHOU OUHAI CHANGHONG GLASSES CO., LTD. China
 
EAE-1040705-2/1/1 11-Jun-2013 86HQY 3009320427 WENZHOU JINZHOU GROUP INTERNATIONAL TRADE CORPORATION LTD. China
 
ENP-1022997-6/5/1 11-Jun-2013 86HQY 3010000219 Guangzhou Sunland Optical China
 
K80-2001192-1/1/1 12-Jun-2013 86HQY 3002245668 Radient Enterprise Co Ltd Taiwan
 
112-2324371-4/1/1 12-Jun-2013 86HQY 3006599808 Xiamen Sun Haven Optical Co. Ltd. China
 
R12-0046651-3/5/1 13-Jun-2013 86HQY 3010096692 Chopard Italia S.R.L. Italy
 
112-2881180-4/52/1 14-Jun-2013 86HQY 3003960934 Wenzhou Cereals Oils & Foodstu China
 
112-2881180-4/52/2 14-Jun-2013 86HQY 3008148231 Dongguan Ialin Optical Mfg Co. Ltd China
 
112-2881180-4/52/3 14-Jun-2013 86HQY 3008770700 Xiamen Zhongshi Optical Industry Co., Ltd. China
 
112-2881180-4/52/4 14-Jun-2013 86HQY 3005925379 Ever Eyewear Co., Ltd China
 
112-2881180-4/52/5 14-Jun-2013 86HQY 3009037205 Ks Lye Apparelglobal Co., Ltd China
 
112-2881180-4/52/6 14-Jun-2013 86HQY 3008198593 Wenzhou Royal Optical Co.,Ltd China
 
112-2881180-4/52/7 14-Jun-2013 86HQY 3006351337 Wenzhou Sunshades Import & Export Corporation Ltd. China
 
112-2881180-4/52/8 14-Jun-2013 86HQY 3007536584 Wenzhou Union Eyew China
 
AEK-0853216-6/1/1 14-Jun-2013 86HQY 3004092287 Shaanxi Kingshine Import China
 
E94-1144096-5/2/1 18-Jun-2013 86HQY 3010197017 LINHAI CITY ZHENXIAN GLASSES FACTORY China
 
WDN-9268960-4/2/1 18-Jun-2013 86HQY 3003387944 Dongguan Wellko Shoes Factory Limited China
 
112-2986756-5/2/1 20-Jun-2013 86HQY 3009834557 Shanghai Xinzi Networks Science China
 
370-0136059-5/1/1 21-Jun-2013 86HQY 3007621404 Shenzhen Xingmei Fashion Co Ltd China
 
AEK-9183830-6/1/1 25-Jun-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
AEK-9182444-7/1/1 26-Jun-2013 86HQY 3009849435 Zhejiang Bingking Glasses Factory China
 
112-3148567-9/1/1 27-Jun-2013 86HQY 3010222917 Linhai Yinloong Ey China
 
BNW-0134139-6/9/1 28-Jun-2013 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
WDN-9268960-4/1/1 18-Jun-2013 86HQZ 3003387944 Dongguan Wellko Shoes Factory Limited China
 
112-2986756-5/1/1 20-Jun-2013 86HQZ 3009834557 Shanghai Xinzi Networks Science China
 
DO7-8285478-3/1/1 26-Jun-2013 86HQZ 3008754720 Wenzhou Howls Fore China
 
112-3166518-9/1/1 28-Jun-2013 86HQZ 3010214122 Hong Feng Intl Co China
 
KT5-0278876-5/2/1 03-Jun-2013 86KYD 3009082984 Aadpri Ophthalmic Company India
 
XXX-0180773-5/1/1 12-Jun-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
XXX-0180773-5/1/2 12-Jun-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
XXX-0180773-5/1/3 12-Jun-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
315-8161832-4/3/1 25-Jun-2013 86LQB 1000206694 Nidek Co., Ltd. Japan
 
112-2653188-3/6/1 06-Jun-2013 86MVN 3008034930 Vassen Co Ltd Korea, Republic Of (South)
 
BSF-0020192-9/1/1 10-Jun-2013 86MYC 3002807715 NIDEK Co., Ltd., Hamacho Plant Japan
 
315-8161832-4/5/1 25-Jun-2013 86MYC 1000206694 Nidek Co., Ltd. Japan
 
M76-2078831-7/1/1 27-Jun-2013 86NJH 3000987080 ESSILOR CANADA LTD. Canada
 
M76-2078831-7/2/1 27-Jun-2013 86NJH 3001252517 Rodenstock Optische Werke Germany
 
M76-2078831-7/3/1 27-Jun-2013 86NJH 1000180234 Carl Zeiss Optical Inc Canada
 
M76-2078831-7/4/1 27-Jun-2013 86NJH 3001252517 Rodenstock Optische Werke Germany
 
M76-2078831-7/5/1 27-Jun-2013 86NJH 3002398337 Carl Zeiss Vision GmbH Germany
 
KT5-0278876-5/3/1 03-Jun-2013 86NYK 3009082984 Aadpri Ophthalmic Company India
 
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