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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
112-8941534-6/1/2 21-Aug-2012 86HJL 3005755367 Shanghai Mediworks Precision Instruments Co. Ltd. China
 
112-8941534-6/1/1 21-Aug-2012 86HJO 3005755367 Shanghai Mediworks Precision Instruments Co. Ltd. China
 
112-8741510-8/1/1 21-Aug-2012 86HKO 3009667452 Xinchang High Fashion Silk Science China
 
AZW-0061908-4/1/1 06-Aug-2012 86HKX 3004451784 Huvitz Co Korea, Republic Of (South)
 
AZW-0060929-1/1/3 01-Aug-2012 86HLM 3005981123 Meda Co., Ltd. China
 
AZW-0060929-1/1/1 01-Aug-2012 86HLM 3005981123 Meda Co., Ltd. China
 
AZW-0060929-1/1/2 01-Aug-2012 86HLM 3005981123 Meda Co., Ltd. China
 
112-8803522-8/1/1 24-Aug-2012 86HOI 3009412615 Moon Fashion Hong Kong SAR
 
112-7774668-6/1/1 07-Aug-2012 86HPB 3008871352 Crystal Optic Industries Ltd. Israel
 
112-8566527-4/1/1 28-Aug-2012 86HQD 3009649478 Juthamanee Buatoom Thailand
 
112-8553778-8/1/1 10-Aug-2012 86HQG 3009630814 Guangzhou Yifang Co Ltd China
 
BTF-4012777-7/1/1 15-Aug-2012 86HQG 3003499479 Wenzhou M & C Foreign Trade Co., Ltd. China
 
112-8730339-5/3/1/A 17-Aug-2012 86HQG 3005742067 Al Harmoodi Computer Systems United Arab Emirates
 
112-8796879-1/1/1 30-Aug-2012 86HQL 3008919873 Freedom Opthalmic Pvt Ltd India
 
CDU-0101203-3/5/1 01-Aug-2012 86HQY 3008781125 Shenzhen Qunkang Industrial Co Ltd China
 
E74-0214122-0/1/1 01-Aug-2012 86HQY 2000009583 DONGYING HUAYU IMPORT AND EXPORT CO.,LTD. China
 
112-8158609-4/1/1 02-Aug-2012 86HQY 3009604575 Qiyi Toys Factory China
 
R12-0044742-2/1/1 06-Aug-2012 86HQY 3009447717 Luxottica Srl Italy
 
R12-0044820-6/1/1 06-Aug-2012 86HQY 3001556165 Luxottica Tristar (Dong Guan) Optical Co., Ltd. China
 
112-7927904-1/1/1 07-Aug-2012 86HQY 3009578733 Via Italy
 
112-7959186-6/2/1 09-Aug-2012 86HQY 3009581003 Kapil Paliwal India
 
AEK-0408041-8/6/1 10-Aug-2012 86HQY 3009635208 You Shang Fang Trading Inc China
 
112-8471119-4/1/1 10-Aug-2012 86HQY 3006537839 LINHAI SHIFENG PET PRODUCT CO.,LTD. China
 
MD8-0034874-8/3/1 10-Aug-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
GL5-0280057-3/1/1 15-Aug-2012 86HQY 3009272928 Taizhyou City Wangye General Gasline Eagine Co Ltd China
 
112-8938910-3/1/1 16-Aug-2012 86HQY 3004521931 Wenzhou Success Group Co., Ltd. China
 
UPS-7288004-6/1/1 24-Aug-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
EG6-2632511-2/3/1 27-Aug-2012 86HQY 3006599808 Xiamen Sun Haven Optical Co. Ltd. China
 
G51-0377870-2/1/1 30-Aug-2012 86HQY 3009670929 Wenzhou Jintai Optical Co., Ltd China
 
112-8212826-8/1/1 31-Aug-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
112-8905738-7/1/1 31-Aug-2012 86HQY 3007804388 Huadu Hua-Pei Garment Factory China
 
E7J-0015755-1/17/1 01-Aug-2012 86HQZ 3003902882 Multi Vision Inc. Korea, Republic Of (South)
 
112-8426687-6/1/1 06-Aug-2012 86HQZ 3003261150 Hoon Sung Optical Co. Korea, Republic Of (South)
 
112-8426687-6/1/3 06-Aug-2012 86HQZ 3003261150 Hoon Sung Optical Co. Korea, Republic Of (South)
 
112-8426687-6/1/2 06-Aug-2012 86HQZ 3003261150 Hoon Sung Optical Co. Korea, Republic Of (South)
 
BDX-0050742-9/1/1 14-Aug-2012 86HQZ 3008954211 Bestwork Industries Limited China
 
112-8548976-6/1/1 15-Aug-2012 86HQZ 3009646627 Emmanuel Optical Group Co., Ltd. China
 
AEK-0407049-2/2/1 02-Aug-2012 86LPL 3008922180 Superstar Bv Netherlands
 
UPS-6988408-4/2/1 03-Aug-2012 86LPL 3009632352 Itala Dezordi Italy
 
ATE-0119570-8/1/2 03-Aug-2012 86LPL 3006681297 Interojo Inc Korea, Republic Of (South)
 
XXX-0178448-9/1/1 06-Aug-2012 86LPL 3003799869 Neo Vision of Korea Korea, Republic Of (South)
 
112-8280674-9/1/1 07-Aug-2012 86LPL 3009618509 Amphend Tech Zhuhai Co Ltd China
 
112-8622722-3/1/1 10-Aug-2012 86LPL 3009654850 Devlyn Optica Mexico
 
336-7363637-3/14/1 24-Aug-2012 86LPL 3006725976 Coopervision Caribbean United States
 
112-4832805-1/1/1 31-Aug-2012 86LPL 3009073335 Bodyjewellleryshop Ltd United Kingdom
 
UPS-7424651-9/1/1 29-Aug-2012 86LPM 3008045675 Aspiration Intl Hong Kong SAR
 
112-8444204-8/1/1 09-Aug-2012 86MSS 3008920118 R.E.T. INC. Korea, Republic Of (South)
 
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