Refusal Actions by FDA as Recorded in OASIS for Japan
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Japan Sangaria Beverage Co., Ltd
Osaka , JP 546 CHI-DO 503-0168614-8/5/1
31KGE02 TEA, GREEN;PLASTIC, SYNTH;PACKAGED FOOD (NOT COMMERCIALLY ST
01-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd
Osaka , JP 546 CHI-DO 503-0168614-8/6/1
31KGE02 TEA, GREEN;PLASTIC, SYNTH;PACKAGED FOOD (NOT COMMERCIALLY ST
01-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd
Osaka , JP 546 CHI-DO 503-0168614-8/7/1
31KGE03 TEA, OOLONG;PLASTIC, SYNTH;PACKAGED FOOD (NOT COMMERCIALLY S
01-MAY-2008 NO PROCESS
Mannatech Japan, Inc.
Tokyo JP-NOTA, JP 108-0075 SWI-DO 534-1803857-5/1/1
41CFB99 GLYCENTIALS, MINERAL DIETARY SUPPLEMENT
05-MAY-2008 LIST INGRE
DIETARY
Santa Trading Co., Ltd.
Nagoya , JP LOS-DO 610-2830282-8/2/1
33CGT06 FRUIT CANDY
06-MAY-2008 UNSAFE COL
Santa Trading Co., Ltd.
Nagoya , JP LOS-DO 610-2830282-8/2/2
33JHB06 SOFT CANDY
06-MAY-2008 UNSAFE COL
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009905-4/3/1
31KGT02 GREEN TEA 350 PET
08-MAY-2008 NO PROCESS
Olympus Medical Systems Corp.
Tokyo , JP FLA-DO 510-5466468-8/1/1
78K--GE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
12-MAY-2008 REGISTERED
Toasu Co., Ltd.
Aichi Pref , JP LOS-DO HG4-0009902-1/1/1
29AET07 TUBUMI MANGO
12-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009902-1/2/1
31KGT03 OOLONG TEA 500ML PET SOFT DRINK
12-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009904-7/1/1
31KGT03 OOLONG TEA 500 PET SOFT DRINK
12-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009904-7/2/1
31KGT02 GREEN TEA SOFTDRINK 500 PET
12-MAY-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009904-7/3/1
31KGT02 GREEN TEA SOFTDRINK PET 2L
12-MAY-2008 NO PROCESS
Japan Foods Co., Ltd.
Chosei-Gun , JP LOS-DO HG4-0009904-7/4/1
31KGT03 OOLONG TEA PET 2L SOFT DRINK
12-MAY-2008 NO PROCESS
Nidek Co., Ltd., Hamacho Plant
Gamagori -Shi , JP 4430036 FLA-DO 793-0603311-3/1/1
86L--ZS EXCIMER LASER SYSTEM
14-MAY-2008 NO PMA
Katookichi Co. Ltd
Niigata , JP SAN-DO 597-0150157-5/12/1
37BGT99 PREPARED RICE
16-MAY-2008 NEEDS FCE
NO PROCESS
Katookichi Co. Ltd
Niigata , JP SAN-DO 597-0150157-5/12/2
37BGT99 PREPARED RICE
16-MAY-2008 NEEDS FCE
NO PROCESS
Osawa Japan Kabushiki Gaisha
Saitama , JP 335-0021 SAN-DO 597-0151097-2/22/4
27VCT99 VEGETABLE CURRY SAUCE
16-MAY-2008 NEEDS FCE
NO PROCESS
Fujisawa Shoji Co.
Kumagaya, Saitama , JP ATL-DO ATK-4009242-2/7/1
16AGH33 FROZEN BOILED ANCHOVY
21-MAY-2008 INSANITARY
Yamashinaya Co
Nagoya , JP ATL-DO ATK-4009242-2/9/1
03YGT12 FROZEN RICE CAKE
21-MAY-2008 UNSAFE COL
Yamashinaya Co
Nagoya , JP ATL-DO ATK-4009242-2/10/1
03YGT12 FROZEN RICE CAKE
21-MAY-2008 UNSAFE COL
Yamashinaya Co
Nagoya , JP ATL-DO ATK-4009242-2/11/1
03YGT12 FROZEN RICE CAKE
21-MAY-2008 UNSAFE COL
Yamashinaya Co
Nagoya , JP ATL-DO ATK-4009242-2/12/1
03YGT12 FROZEN RICE CAKE
21-MAY-2008 UNSAFE COL
Marukai Foods
Hiroshima , JP ATL-DO ATK-4008796-8/9/1
16AGH33 COOKED/DRIED WHOLE ANCHOVY
21-MAY-2008 FILTHY
Marukai Foods
Hiroshima , JP ATL-DO ATK-4008796-8/10/1
16AGH33 COOKED / DRIED WHOLE ANCHOVY
21-MAY-2008 FILTHY
NISHIKAWA CO.,LTD
SAIKI-GUN JP-34, JP 738-0514 ATL-DO ATK-4008796-8/11/1
16AGH33 FROZEN BOILED ANCHOVY
21-MAY-2008 FILTHY
MARUTOMO CO., LTD.
Iyo City JP-38, JP 799-3192 ATL-DO ATK-4008796-8/12/1
16AGH33 COOKED / DRIED WOLE ANCHOVY
21-MAY-2008 FILTHY
Marukai Foods
Hiroshima , JP ATL-DO ATK-4009162-2/6/1
16AGH33 COKKED / DRIED WHOLE ANCHOVY
21-MAY-2008 FILTHY
Marukai Foods
Hiroshima , JP ATL-DO ATK-4009162-2/7/1
16AGH33 COOKED / DRIED WHOLE ANCHOVY
21-MAY-2008 FILTHY
NISHIKAWA CO.,LTD
SAIKI-GUN JP-34, JP 738-0514 ATL-DO ATK-4009162-2/8/1
16AGH33 FROZEN BOILED ANCHOVY
21-MAY-2008 FILTHY
MARUTOMO CO., LTD.
Iyo City JP-38, JP 799-3192 ATL-DO ATK-4009162-2/9/1
16AGH33 COOKED / DRIED WHOLE ANCHOVY
21-MAY-2008 FILTHY
Matsushita Electric Industrial
Osaka , JP 0 0 FLA-DO 406-0416215-2/2/1
94R--BB CRT ELECTRONIC VIEW FINDER - **FOR EXPORT ONLY***
23-MAY-2008 NON STD
Matsushita Electric Industrial
Osaka , JP 0 0 FLA-DO 406-0416215-2/5/1
94R--BB LIQUID CRYSTAL COLOR VIDEO MONITOR - ***FOR EXPORT ONLY***
23-MAY-2008 NON STD
Matsushita Electric Industrial
Osaka , JP 0 0 FLA-DO 406-0416215-2/7/1
94R--BB MEMORY CARD DRIVE ***FOR EXPORT ONLY***
23-MAY-2008 NON STD
Matsushita Electric Industrial
Osaka , JP 0 0 FLA-DO 406-0416215-2/8/1
94R--BB MEMORY CARD VIDEO RECORDER ***FOR EXPORT ONLY***
23-MAY-2008 NON STD
Yamajin Co., Ltd
Oita , JP SAN-DO 597-0151657-3/2/1
16AGH33 FROZEN BOILED DRIED SARDINES
23-MAY-2008 MFR INSAN
Yoshimura Shoten Co Ltd
Karatsu Saga, JP SAN-DO 597-0151657-3/2/3
16AGH36 FROZEN DRIED LONGFIN SMELT
23-MAY-2008 MFR INSAN
Neways Japan Kk
Kanagawa , JP LOS-DO AEK-7749883-6/1/1
41BET99 Pro-Thin Pre-meal Tablet
26-MAY-2008 NO ENGLISH