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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 78-Gastroenterological & Urological


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
Manufacturer
Country/Area
UPS-3990263-2/1/1/B 07-Feb-2014 78FAF 3010633585 Mandax Limited United Kingdom
 
UPS-3947709-8/1/3 12-Feb-2014 78FAS 3010316871 Lianliang Industrial Developing Ltd China
 
799-2362253-8/1/1 24-Feb-2014 78FGB 1218764 Gyrus ACMI, Inc. United States
 
FR1-0015430-6/1/1 11-Feb-2014 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015437-1/1/1 14-Feb-2014 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015440-5/1/1 14-Feb-2014 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015438-9/2/1 24-Feb-2014 78FJI 3002807710 Nipro Corporation - Ohdate Factory Japan
 
FR1-0015436-3/1/1 14-Feb-2014 78FKP 3007482089 Miyuki Elex Co.,Ltd Japan
 
FR1-0015436-3/2/1 14-Feb-2014 78FKP 3007245589 Shibuya Kogyo Co Ltd Japan
 
WG1-0233990-9/19/1 26-Feb-2014 78KNT 3002806934 Kendall Company L.P. Mexico
 
231-1557714-4/1/37 27-Feb-2014 78KNT 3002806436 Avent S.A. De C.V. Mexico
 
231-1557714-4/1/66 27-Feb-2014 78KNT 3002806436 Avent S.A. De C.V. Mexico
 
799-2425928-0/1/1 03-Feb-2014 78LKY 3009094607 Nice Dream International Ltd. China
 
799-2230719-8/3/1 03-Feb-2014 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-2468882-7/3/1 03-Feb-2014 78LKY 3005529175 California Exotica United States
 
799-2313884-0/7/1 03-Feb-2014 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-2313884-0/2/1 03-Feb-2014 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-2455434-2/4/1 03-Feb-2014 78LKY 3006782834 Best Green China
 
799-2535401-5/1/1 03-Feb-2014 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-2343234-2/2/1 04-Feb-2014 78LKY 3007335337 Ultramax Products United Kingdom
 
799-2405694-2/3/1 05-Feb-2014 78LKY 3006782834 Best Green China
 
799-2359746-6/1/1 05-Feb-2014 78LKY 3010547824 Tantus Inc United States
 
799-2424834-1/1/1 07-Feb-2014 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-2426743-2/1/1 07-Feb-2014 78LKY 3007197519 Gopaldas Hong Kong SAR
 
799-2511100-1/3/1 07-Feb-2014 78LKY 3009608482 Bathmate Direct United Kingdom
 
799-2721489-4/1/1 12-Feb-2014 78LKY 3005615971 ORBISAN LTD Malta & Gozo
 
799-2594074-8/1/1 14-Feb-2014 78LKY 3003114623 Phsi Inc. United States
 
799-2525418-1/2/1 14-Feb-2014 78LKY 3010586843 Lovehoney-Best Green China
 
799-2699357-1/1/1 24-Feb-2014 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-2906065-9/1/1 28-Feb-2014 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-2906065-9/2/1 28-Feb-2014 78LKY 3009510223 Um Products Ltd United Kingdom
 
799-2755904-1/1/1 28-Feb-2014 78LKY 3009510223 Um Products Ltd United Kingdom
 
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