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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
AGA-0019677-7/1/2 04-Mar-2013 86HJO 3008033898 Shanghai Canary Accessories Co Ltd China
 
112-1581614-7/1/1 01-Mar-2013 86HKL 3008945575 Infushion Equipments Inc India
 
AGA-0019677-7/1/1 04-Mar-2013 86HLF 3008033898 Shanghai Canary Accessories Co Ltd China
 
BNW-3133312-4/2/1 29-Mar-2013 86HOI 3007120545 Kerview S.A. Uruguay
 
BSF-0019386-0/1/1 04-Mar-2013 86HPI 3002743821 Avnet Medical Equipment Ltd. Israel
 
112-1219435-7/1/1 01-Mar-2013 86HQG 3006066935 Coastal Contacts Inc. Canada
 
112-1676458-5/1/1 07-Mar-2013 86HQG 3008537565 Wintec International Japan Inc. Japan
 
112-1373140-5/1/1 01-Mar-2013 86HQY 3006747035 Pucheng Mincheng Optics Glasses Co China
 
112-9784913-0/2/1 01-Mar-2013 86HQY 3009782486 Abound Texfactory China
 
112-0542214-6/1/1 01-Mar-2013 86HQY 3009867866 Sunrise Trade Link Ltd China
 
112-1363961-6/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-1367622-0/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-1397564-8/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-1397724-8/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-1397878-2/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-1398984-7/1/1 01-Mar-2013 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
UPS-8392056-7/7/1 04-Mar-2013 86HQY 3007719624 Coastal Contacts Canada
 
112-7052900-5/1/1 04-Mar-2013 86HQY 3005737816 Ena Optical Manufacturing Co. Japan
 
AEK-0292682-8/4/1 04-Mar-2013 86HQY 3009868163 Harken Mauritius Mauritius
 
231-5522489-6/3/1 07-Mar-2013 86HQY 3008324215 Kosway Industries Co Ltd China
 
BOY-0003151-5/15/1 07-Mar-2013 86HQY 3010028830 Pacific Entermark Taiwan
 
UPS-9660446-3/1/1 12-Mar-2013 86HQY 3004521931 Wenzhou Success Group Co., Ltd. China
 
BQK-2167552-4/1/1 14-Mar-2013 86HQY 3003636174 Wenzhou Lucheng Xinxing Glasses Factory China
 
AEK-0787822-2/1/1 14-Mar-2013 86HQY 3004026708 Starlite Optical Manufactory China
 
AEK-0787822-2/1/2 14-Mar-2013 86HQY 3004026708 Starlite Optical Manufactory China
 
AEK-0787822-2/6/1 14-Mar-2013 86HQY 3007001355 Premier Devices In China
 
AEK-0787822-2/3/1 14-Mar-2013 86HQY 1000284573 See Kiang Optical Manufactory Co.Ltd. Hong Kong SAR
 
AEK-0787822-2/2/1 14-Mar-2013 86HQY 3003972702 United Creation Optical China
 
AEK-0787822-2/4/1 14-Mar-2013 86HQY 3004026708 Starlite Optical Manufactory China
 
AEK-0787822-2/5/1 14-Mar-2013 86HQY 3003972702 United Creation Optical China
 
AVB-0474053-2/1/1 21-Mar-2013 86HQY 3003158815 Histoire De Voir France
 
112-1821228-6/11/1 22-Mar-2013 86HQY 1000469032 Wenzhou Center Optical Co., Ltd. China
 
AEK-0296667-5/1/1 26-Mar-2013 86HQY 3000595787 Shenzhen Long Hua Toppy Honest Toy China
 
U35-3480286-4/3/1 26-Mar-2013 86HQY 3007108638 High Tech Optical Co. Japan
 
112-1882629-1/1/1 29-Mar-2013 86HQY 3009417353 King Fai Plastic & Toys Co China
 
BNW-3133312-4/1/1 29-Mar-2013 86HQY 3007120545 Kerview S.A. Uruguay
 
112-0302585-9/1/1 29-Mar-2013 86HQY 3009690476 Taizhou Jiaojiang Zheshang Glasses Ltd China
 
D99-3243953-9/1/1 29-Mar-2013 86HQY 3002288242 Wenzhou Taili Glasses Co., Ltd. China
 
AN1-0585431-7/1/1 08-Mar-2013 86HQZ 3004859835 Zhejiang Xielang O China
 
AEK-0787822-2/7/1 14-Mar-2013 86HQZ 1000426596 Cheng Yi Plastic Ind. Co., Ltd. China
 
112-2129797-7/1/1 21-Mar-2013 86HQZ 3009058030 Onnury Optical Company Korea, Republic Of (South)
 
112-1821228-6/7/1 22-Mar-2013 86HQZ 3005592976 Eagle Int'L Ltd China
 
112-1821228-6/8/1 22-Mar-2013 86HQZ 3006648630 United Creation China
 
112-1821228-6/10/1 22-Mar-2013 86HQZ 3007049438 Di Ware China
 
112-1821228-6/9/1 22-Mar-2013 86HQZ 3006648630 United Creation China
 
112-1821228-6/4/1 22-Mar-2013 86HQZ 1000241163 Kunwha Optical Co. Korea, Republic Of (South)
 
112-1870140-3/1/1 22-Mar-2013 86HQZ 1000368145 ETS Louis Cabaud & Fils France
 
112-0305685-4/1/1 29-Mar-2013 86HQZ 3005734448 Jojo Optical Co., Ltd China
 
112-1614525-6/1/1 19-Mar-2013 86KYH 3008789341 Shinjuku Monlith Japan
 
112-1243940-6/1/1 01-Mar-2013 86LPL 3009971436 Avizor S.A. Spain
 
UPS-9542461-6/1/1 05-Mar-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-1423818-6/2/1 14-Mar-2013 86LPL 1000222023 Johnson & Johnson Vision Care, Inc. United States
 
EAM-0014388-2/1/1 18-Mar-2013 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
MYK-3913423-1/1/1 20-Mar-2013 86LPL 3003247407 Bescon Co., Ltd. Korea, Republic Of (South)
 
UPS-0132753-7/1/1 25-Mar-2013 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
UPS-0272172-0/1/1/A 25-Mar-2013 86LPL 3008612284 Innova Vision Inc China
 
UPS-0272172-0/1/1/B 25-Mar-2013 86LPL 3008612284 Innova Vision Inc China
 
112-0335750-0/1/1 29-Mar-2013 86LPL 3008722560 Oculus Private Limted Singapore
 
UPS-7984178-5/1/1 29-Mar-2013 86LPL 3008198551 Direkt Kuriedienst Gmbh Austria
 
112-1642171-5/1/1 29-Mar-2013 86LPL 3006437593 Ben Thanh Gifts Shop Vietnam
 
112-1635725-7/1/1 08-Mar-2013 86LZS 3009978783 Iroc Innocross Ag Switzerland
 
112-1691971-8/1/1 04-Mar-2013 86MUW 3010030660 Fantasmagoria Lithuania
 
112-1373140-5/2/1 01-Mar-2013 86NJH 3006747035 Pucheng Mincheng Optics Glasses Co China
 
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