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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
201-1380699-5/1/1 10-Dec-2012 86HLI 3009828906 Unicos Co Ltd Korea, Republic Of (South)
 
DO7-8401637-3/1/1 27-Dec-2012 86HMG 3005537753 Global Vision Corporation China
 
UPS-9024252-6/10/1 20-Dec-2012 86HOI 3009739923 Wenzhou New Century International C China
 
UPS-8484783-5/1/1 05-Dec-2012 86HQY 3009280590 Pel United Kingdom
 
UPS-8468082-2/1/1 05-Dec-2012 86HQY 3009280590 Pel United Kingdom
 
UPS-8431319-2/1/1 05-Dec-2012 86HQY 3003116697 Safilo Group S.p.A. Italy
 
UPS-8617632-4/1/1 05-Dec-2012 86HQY 3009836713 Prescription Eyewear Limited United Kingdom
 
UPS-8667411-2/1/1 06-Dec-2012 86HQY 3009834232 Prescription Eyewear Ltd United Kingdom
 
UPS-8667411-2/2/1 06-Dec-2012 86HQY 3009834232 Prescription Eyewear Ltd United Kingdom
 
UPS-8609917-9/1/1 10-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8619180-2/1/1 10-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8619463-2/1/1 10-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8615744-9/1/1 10-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8581934-6/1/1 10-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8634394-0/1/1 11-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8620083-5/1/1 11-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8622133-6/1/1 11-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8635377-4/1/1 11-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8624650-7/1/1 11-Dec-2012 86HQY 2938320 Maui Jim Inc United States
 
UPS-8634071-4/1/1 11-Dec-2012 86HQY 3003116697 Safilo Group S.p.A. Italy
 
UPS-8860889-4/1/1 13-Dec-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
UPS-8685981-2/1/1 13-Dec-2012 86HQY 3003116697 Safilo Group S.p.A. Italy
 
UPS-8675770-1/1/1 14-Dec-2012 86HQY 1000281480 Maudal S.A. France
 
EJ7-0073354-9/1/1 17-Dec-2012 86HQY 3002810592 Luxottica Group S.P.A. Italy
 
112-0559468-8/1/1 19-Dec-2012 86HQY 3008252163 Linhai City Qianbaidu Glasses Factory China
 
551-0450382-2/5/1 20-Dec-2012 86HQY 3009134681 Wenzhou Imp & Exp United Co Ltd China
 
336-7640070-2/6/1 21-Dec-2012 86HQY 3009855091 Golf Pros And Am Sa De Cv Mexico
 
112-0561335-5/4/3 26-Dec-2012 86HQY 3005990481 Shenzhen Ye Jun Enterprise Co. China
 
112-0561335-5/4/2 26-Dec-2012 86HQY 3005990481 Shenzhen Ye Jun Enterprise Co. China
 
112-0561335-5/4/4 26-Dec-2012 86HQY 3005990481 Shenzhen Ye Jun Enterprise Co. China
 
112-0561335-5/4/1 26-Dec-2012 86HQY 3005990481 Shenzhen Ye Jun Enterprise Co. China
 
BNW-2122619-7/5/1 26-Dec-2012 86HQY 3004611290 Scorpio Distributors United Kingdom
 
MN8-1046856-6/1/1 27-Dec-2012 86HQY 3009810842 Finemaster International Traders Ltd China
 
112-0360818-3/1/1 21-Dec-2012 86HQZ 3004535542 Schnuchel Germany
 
112-0196564-3/1/1 03-Dec-2012 86LPL 3008585940 GEO Medical Co., Ltd. Korea, Republic Of (South)
 
112-0472315-5/1/1 17-Dec-2012 86LPL 3009858637 Direct Wholesale Ltd United Kingdom
 
AEK-0612825-6/1/1 04-Dec-2012 86LYL 3008744603 All Animal Eye Services Australia
 
112-0472315-5/2/1 17-Dec-2012 86LYL 3008808511 Beautifeye United Kingdom
 
112-9669997-3/1/1 03-Dec-2012 86MVN 3007270084 Ciba Vision Johor Sdn Bhd Malaysia
 
UPS-8509986-5/1/1 06-Dec-2012 86NJH 3009280590 Pel United Kingdom
 
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