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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
286-1652511-0/1/1 26-Jan-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652511-0/2/1 26-Jan-2011 86HJB 3002680900 Tomey Corporation Japan
 
EE6-0125464-6/1/1 13-Jan-2011 86HKI 3008422902 Centervue Spa Italy
 
112-0258720-5/1/1 28-Jan-2011 86HKN 3005515335 Wenzhou Dongwu Optical Instrument Co., Ltd. China
 
BNW-0025820-3/15/1 11-Jan-2011 86HOI 3005715538 Duty Free Air And Ship Supply Co United States
 
734-0045496-0/1/1 20-Jan-2011 86HOI 3008155506 Wenzhou Hongjian Optics Co., Ltd. China
 
BNW-0026075-3/15/1 31-Jan-2011 86HOI 3005715538 Duty Free Air And Ship Supply Co United States
 
112-7374509-4/1/1 04-Jan-2011 86HQG 3002711488 Ramassia United States
 
112-6791603-2/1/1 05-Jan-2011 86HQG 3007292719 Centro Integral Optico Sa Cv Mexico
 
112-6700245-2/1/1 06-Jan-2011 86HQG 3007413019 Aladham Opticals Oman
 
112-5219143-6/1/1 06-Jan-2011 86HQG 3003778868 Rodenstock (Thailand) Co., Ltd. Thailand
 
112-5219143-6/2/1 06-Jan-2011 86HQG 3002571872 Vision Ease United States
 
231-3988685-0/1/1 20-Jan-2011 86HQG 3007235871 Zhenjiang Wanxin Optical Co., Ltd China
 
WMK-1012060-2/1/1 31-Jan-2011 86HQL 3008080186 Milliennium Biomedical Inc United States
 
442-7223061-4/22/1 03-Jan-2011 86HQY 3008463604 Edolo International Co., Ltd China
 
442-7223073-9/193/1 03-Jan-2011 86HQY 3008463604 Edolo International Co., Ltd China
 
442-7223072-1/193/1 03-Jan-2011 86HQY 3008463604 Edolo International Co., Ltd China
 
R12-0042179-9/1/1 10-Jan-2011 86HQY 3003116697 Safilo Group S.p.A. Italy
 
BNW-0026063-9/3/1 11-Jan-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0025976-3/9/1 11-Jan-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0026097-7/10/1 14-Jan-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
P09-2000959-7/3/1 25-Jan-2011 86HQY 3001657517 Lucxotica Spa Italy
 
BNW-0026022-5/14/1 26-Jan-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
AEK-8595844-1/1/1 28-Jan-2011 86HQY 3008715655 Calconix Asia China
 
112-5252579-9/1/1 06-Jan-2011 86LPL 3008046564 Bao Dao Glasses Co. Ltd China
 
112-6994470-1/1/1 05-Jan-2011 86LPM 3005994941 Solotica Brazil
 
112-6831322-1/1/1 05-Jan-2011 86LPM 3005994941 Solotica Brazil
 
112-6821785-1/1/1 05-Jan-2011 86LPM 3005994941 Solotica Brazil
 
112-5251878-6/1/1 06-Jan-2011 86LPM 3004894187 Geo Medical Co., Ltd. Korea, Republic Of (South)
 
CAY-1024868-7/1/1 13-Jan-2011 86LPM 3008546291 New Bio Co Ltd Korea, Republic Of (South)
 
CAY-1024868-7/2/1 13-Jan-2011 86LPM 3008546291 New Bio Co Ltd Korea, Republic Of (South)
 
112-6587546-1/2/3 06-Jan-2011 86MSI 3003023771 Roche Pharmaceuticals Canada
 
112-7730915-2/1/1 04-Jan-2011 86MVN 3007159669 L F Garbelini Otica Me Brazil
 
112-6732125-8/1/1 05-Jan-2011 86MVN 3004563779 Baush & Lomb Inc United States
 
XXX-0252112-9/1/1 31-Jan-2011 86MZD 3005994941 Solotica Brazil
 
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