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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
GL9-0812032-9/1/1 23-Feb-2009 86HNR 3000176638 Asico United States
 
GL9-0812032-9/1/2 23-Feb-2009 86HNX 3000176638 Asico United States
 
U83-0766396-2/1/1 02-Feb-2009 86HOI 3005325805 Wenzhou Lucheng East Optical Fac China
 
ES3-2024069-1/1/1 10-Feb-2009 86HOI 3004997532 Suntan Industrial Co Ltd Taiwan
 
BNW-0821883-7/12/1 13-Feb-2009 86HOI 3005715538 Duty Free Air And Ship Supply Co United States
 
112-6457630-0/1/1 27-Feb-2009 86HQG 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
322-5083048-9/1/1 05-Feb-2009 86HQY 3004779055 Safilo Far East Ltd Hong Kong SAR
 
BVQ-0022326-2/1/1 10-Feb-2009 86HQY 3004868401 Wenzhou Union Eyewear Co., Ltd. China
 
AEK-6881576-6/1/1 13-Feb-2009 86HQY 3007310388 Alpi Of Steven Torris United Kingdom
 
H24-0070759-0/1/1 17-Feb-2009 86HQY 3007335926 Inspecs Distribution Centre United Kingdom
 
H24-0070759-0/2/1 17-Feb-2009 86HQY 3007335926 Inspecs Distribution Centre United Kingdom
 
H24-0070759-0/3/1 17-Feb-2009 86HQY 3007335926 Inspecs Distribution Centre United Kingdom
 
H24-0070759-0/4/1 17-Feb-2009 86HQY 3007335926 Inspecs Distribution Centre United Kingdom
 
750-0127603-1/1/1 25-Feb-2009 86HQY 3006099508 Medal Sports (Taiwan) Corporation Taiwan
 
UPS-3435494-2/1/1 26-Feb-2009 86HQY 3006603569 Hopesun World Business Co., Ltd. China
 
112-6057262-6/1/5 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/4 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/3 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/2 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/1 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/9 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/10 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/7 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/8 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/11 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/12 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/13 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/14 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/15 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/6 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/21 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/16 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/20 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/19 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/18 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/17 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/25 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/23 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/24 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/28 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/27 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/26 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/22 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/32 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/30 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/29 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
112-6057262-6/1/31 02-Feb-2009 86HQZ 3004985659 Hwa Kyung Industrial Co. Korea, Republic Of (South)
 
UPS-2965333-2/3/3 03-Feb-2009 86HQZ 3007217115 Atmosphera Italy
 
UPS-2965333-2/3/4 03-Feb-2009 86HQZ 3007217117 Valottica Italy
 
UPS-2965333-2/4/1 03-Feb-2009 86HQZ 3007217117 Valottica Italy
 
UPS-2965333-2/5/1 03-Feb-2009 86HQZ 3003504159 Gem Lunetterie France
 
112-6156945-6/1/1 06-Feb-2009 86HQZ 3005610857 Wenzhou Yuanyang G China
 
112-6110694-5/1/1 19-Feb-2009 86HQZ 3007315894 Tae Young Corporation Korea, Republic Of (South)
 
112-6532314-0/1/1 25-Feb-2009 86HQZ 3006024203 Aram Eyewear Co Ltd Korea, Republic Of (South)
 
UPS-3522461-5/1/1 26-Feb-2009 86HQZ 3006750739 DANYANG SAN-SINO OPTICAL CO., LTD. China
 
UPS-3522461-5/1/2 26-Feb-2009 86HQZ 3006442348 Dantu Sanshan Clothes-Shoes Factory China
 
112-5703305-3/1/1 05-Feb-2009 86LPL 3002982796 Sauflon Pharmaceuticals Limited United Kingdom
 
112-5820990-0/1/1 24-Feb-2009 86LPL 3007279986 Cheryl Welch United States
 
112-6003528-5/1/1 05-Feb-2009 86LPM 3005994941 Solotica Brazil
 
112-5994582-5/1/1 05-Feb-2009 86NJH 3007292719 Centro Integral Optico Sa Cv Mexico
 
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