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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 Japan


Entry/doc/line/sfx Refusal Date Product
Code
Manufacturer
FEI
Manufacturer
Name
ATK-4030661-6/2/11 03-Jun-2013 03RGT01 1000168314 Minamoto Kitchoan Co.,Ltd.
 
ATK-4030661-6/3/12 03-Jun-2013 21CHT01 1000168314 Minamoto Kitchoan Co.,Ltd.
 
ATK-4030661-6/3/13 03-Jun-2013 21CHT01 1000168314 Minamoto Kitchoan Co.,Ltd.
 
FR1-0015001-5/1/1 03-Jun-2013 78FKP 3007482089 Miyuki Elex Co.,Ltd
 
FR1-0015001-5/2/1 03-Jun-2013 78FKP 3007245589 Shibuya Kogyo Co Ltd
 
FR1-0015001-5/3/1 03-Jun-2013 80FRN 3007482089 Miyuki Elex Co.,Ltd
 
FR1-0015033-8/1/1 03-Jun-2013 80FOZ 3004070915 Hanako Medical
 
FR1-0015059-3/1/1 03-Jun-2013 73BSP 3002807725 Nipro Medical Industries, Ltd.
 
112-2726468-2/1/1 04-Jun-2013 38CET33 3010161333 Ajinobou
 
BSF-0020192-9/1/1 10-Jun-2013 86MYC 3007829571 Nidek Co Ltd
 
231-4292600-9/1/1 10-Jun-2013 89IMD 3005551233 Dia Pharmaceutical Co., Ltd
 
112-2583532-7/1/2/D 17-Jun-2013 66VCY99 3009636430 Sujie Pharmaceutical Ltd
 
FR1-0015083-3/1/1 20-Jun-2013 73BSP 3002807725 Nipro Medical Industries, Ltd.
 
FR1-0015083-3/2/1 20-Jun-2013 78FJI 3002807710 Nipro Corporation - Ohdate Factory
 
112-2987122-9/1/1 21-Jun-2013 74DQY 3008456389 Kitazato Medical Co Ltd
 
112-2987122-9/2/1 21-Jun-2013 79GCB 3008456389 Kitazato Medical Co Ltd
 
315-8161832-4/1/1 25-Jun-2013 86HMC 1000206694 Nidek Co., Ltd.
 
315-8161832-4/2/1 25-Jun-2013 86HKI 1000206694 Nidek Co., Ltd.
 
315-8161832-4/3/1 25-Jun-2013 86LQB 1000206694 Nidek Co., Ltd.
 
315-8161832-4/5/1 25-Jun-2013 86MYC 1000206694 Nidek Co., Ltd.
 
315-8161832-4/8/1 25-Jun-2013 86HJO 1000206694 Nidek Co., Ltd.
 
315-8161832-4/4/1 25-Jun-2013 86HNO 1000206694 Nidek Co., Ltd.
 
315-8161832-4/6/1 25-Jun-2013 86HOS 1000206694 Nidek Co., Ltd.
 
315-8161832-4/7/1 25-Jun-2013 86HOS 1000206694 Nidek Co., Ltd.
 
DE3-0004240-0/48/1 25-Jun-2013 16AGC16 3009749545 True World Japan, Inc.
 
9ES-0015562-0/27/1 27-Jun-2013 25JGP07 3010145032 Taniguchijozo Co Ltd
 
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