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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
286-1652765-2/3/1 06-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/1/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/2/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/6/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/5/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/3/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
286-1652664-7/4/1 12-Apr-2011 86HJB 3002680900 Tomey Corporation Japan
 
M21-0743393-2/1/1 04-Apr-2011 86HKO 3008311655 Manuel Salamanca & Cia Ltda. Colombia
 
251-1460211-0/1/2 05-Apr-2011 86HKX 3007463982 Lianyungang Tiannuo Optical Inst China
 
286-1652765-2/6/1 06-Apr-2011 86HKX 3002680900 Tomey Corporation Japan
 
K80-0994217-9/3/1 07-Apr-2011 86HOI 3004215888 Fuhua (Zhangzhou) Optical Co., Ltd. China
 
UPS-1989942-2/1/1 29-Apr-2011 86HQD 3008868285 Globallens Ent. Ltd. Canada
 
UPS-1989936-4/1/1 29-Apr-2011 86HQD 3008868285 Globallens Ent. Ltd. Canada
 
AEK-8678564-5/1/1 01-Apr-2011 86HQY 1000207591 Ioves Srl Italy
 
R12-0042723-4/1/1 05-Apr-2011 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
R12-0042723-4/2/1 05-Apr-2011 86HQY 3007270352 Kervie S.A Zona Franc Uruguay
 
K80-0994217-9/1/1 07-Apr-2011 86HQY 3001419147 CHENG YI OPTICAL INDUSTRIAL CO., LTD (XIAMEN) China
 
K80-0994217-9/2/1 07-Apr-2011 86HQY 3004010996 Guangzhou Dashin Optics Ent Ltd China
 
K80-0994217-9/4/1 07-Apr-2011 86HQY 3004215888 Fuhua (Zhangzhou) Optical Co., Ltd. China
 
K80-0994217-9/5/1 07-Apr-2011 86HQY 3001064382 HWA MAO Optical Co., Ltd. China
 
DO2-0286187-1/1/1 14-Apr-2011 86HQY 3002538102 Wenzhou Ouhua Foreign Trade Corp. China
 
R12-0042718-4/2/1 17-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0042718-4/1/1 17-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0042718-4/3/1 17-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0042718-4/4/1 17-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0042718-4/5/1 17-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
112-1770522-2/1/1 18-Apr-2011 86HQY 3005555656 Wenzhou Deyuan Trade Development Co., Ltd. China
 
M73-0106893-9/1/1 19-Apr-2011 86HQY 3008811948 Hai Lan Electronics China
 
112-1402008-8/1/2 19-Apr-2011 86HQY 3008826355 Hong Tu Optics Taiwan
 
112-1402008-8/1/1 19-Apr-2011 86HQY 3008826355 Hong Tu Optics Taiwan
 
BNW-0126411-9/10/1 20-Apr-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0126417-6/10/1 20-Apr-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
BNW-0126509-0/6/1 20-Apr-2011 86HQY 3005715538 Duty Free Air And Ship Supply Co United States
 
ENE-0000993-5/1/1 21-Apr-2011 86HQY 3008174886 Wenzhou Lishi Optics Co., Ltd. China
 
R12-0042743-2/2/1 27-Apr-2011 86HQY 3003116697 Safilo Group S.p.A. Italy
 
F23-0530401-6/24/1 27-Apr-2011 86HQY 3008863025 Ninbo Ocean Plastic Chemical Produc China
 
F23-0530401-6/28/1 27-Apr-2011 86HQY 3008863025 Ninbo Ocean Plastic Chemical Produc China
 
R12-0042917-2/1/1 28-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
R12-0042917-2/2/1 28-Apr-2011 86HQY 3001654059 Luxottica SRL Italy
 
DSV-8501293-5/1/1 29-Apr-2011 86HQY 3003517044 Mirage Spa Italy
 
112-1403198-6/1/1 12-Apr-2011 86HQZ 3008169147 James Optical Korea, Republic Of (South)
 
BSF-0009829-1/1/1 14-Apr-2011 86HQZ 3008209494 Han Il Optical Co. Korea, Republic Of (South)
 
UPS-1599813-7/1/1 01-Apr-2011 86LPL 3008045675 Aspiration Intl Hong Kong SAR
 
UPS-1599892-1/1/1 01-Apr-2011 86LPL 3008045675 Aspiration Intl Hong Kong SAR
 
UPS-1599854-1/1/1 01-Apr-2011 86LPL 3008045675 Aspiration Intl Hong Kong SAR
 
112-1334517-1/1/1 27-Apr-2011 86LPL 3004146030 Interojo Inc. Korea, Republic Of (South)
 
UPS-1894709-9/1/1 29-Apr-2011 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
286-1652765-2/1/1 06-Apr-2011 86MMQ 3002680900 Tomey Corporation Japan
 
286-1652765-2/5/1 06-Apr-2011 86MMQ 3002680900 Tomey Corporation Japan
 
DO7-8243182-2/1/1 08-Apr-2011 86MVN 1000573013 Zhenjiang International Economic-Technical Cooperation Corp. China
 
XXX-0270734-8/1/1 04-Apr-2011 86NCZ 3005994941 Solotica Brazil
 
286-1652765-2/4/1 06-Apr-2011 86NFI 3002680900 Tomey Corporation Japan
 
M21-0743393-2/2/1 04-Apr-2011 86NQE 3008311655 Manuel Salamanca & Cia Ltda. Colombia
 
286-1652765-2/2/1 06-Apr-2011 86NQE 3002680900 Tomey Corporation Japan
 
DM9-1100416-4/1/1 20-Apr-2011 86NQE 3006618029 PICHINA OPTICAL CO., LTD Korea, Republic Of (South)
 
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