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
Q.P. Corporation Senkawa Factory
Cyofu-Shi , JP NWE-DO 221-1889210-2/5/2
27AGT02 MAYONNASE
01-OCT-2008 LIST INGRE
LACKS FIRM
LACKS N/C
USUAL NAME
NUTRIT LBL
Toasu Co., Ltd.
Aichi Pref , JP BLT-DO 113-4421974-3/2/1
29AET70 CANNED SOFT DRINK
02-OCT-2008 NO PROCESS
Nof Corporation
Tokyo , JP 150 NOL-DO 112-4359007-5/1/1
66VIP99 790076648139 COATSOME (PHAMACEUTICALS)
02-OCT-2008 NOT LISTED
DIRECTIONS
LACKS FIRM
LACKS N/C
DRUG NAME
UNAPPROVED
Nof Corporation
Tokyo , JP 150 NOL-DO 112-4359007-5/2/1
66VIP99 790076648139 CHOLESTEROL (PHAMACEUTICALS)
02-OCT-2008 NOT LISTED
DIRECTIONS
LACKS FIRM
LACKS N/C
DRUG NAME
UNAPPROVED
Nacalai Tessque Inc
Kyoto , JP 600 SAN-DO 112-4335016-5/1/1
88I--BE 790076644648 NEURAMINANASE
03-OCT-2008 NOT LISTED
REGISTERED
Koshiro Seiyaku Co., Ltd.
Osaka , JP SAN-DO 427-7306393-0/1/1
62MAS08 L-MENTHOL
03-OCT-2008 NOT LISTED
Wako Jyunyaku Kogyo Co Ltd
Osaka , JP SAN-DO 427-7306393-0/2/1
66BAS05 ANHYDROUS CAFFEINE
03-OCT-2008 NOT LISTED
Japan Foods Co., Ltd.
Chosei-Gun , JP CHI-DO HG4-0010450-8/7/1
31KGE03 OOLONG PET 2L SOFT DRINK
07-OCT-2008 NO PROCESS
Ivens S.A.
Nunoa , CL FLA-DO KN2-0006256-7/1/1
95R--ZN MONITOR
07-OCT-2008 NON STD
Hilite Enterprise
Nishi-Tokyonishi-Tokyo , JP 188-0004 CIN-DO UPS-2353728-3/1/1
80B--WJ ACU REFLEX PEN/XACTA 3000, INC./LAKEWOOD, NJ/COMM
08-OCT-2008 NO 510(K)
Sumitomo Corporation
Osaka , JP 540-91 NYK-DO 315-6196903-6/3/1
62CCS30 HYDRALAZINE HCL /FOR APOTEX
08-OCT-2008 NOT LISTED
DIRECTIONS
Toasu Co., Ltd.
Aichi Pref , JP SAN-DO HG4-0011314-5/1/1
29AET07 TUBUMI MANGO
10-OCT-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP SAN-DO HG4-0011314-5/2/1
29AET08 TUBUMI SHIROBUDOU NON-CARB SOFT DRINK
10-OCT-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP SAN-DO HG4-0011314-5/5/1
31KGT02 GREEN TEA SOFTDRINK
10-OCT-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP SAN-DO HG4-0011314-5/6/1
31KGT02 GREEN TEA SOFTDRINK
10-OCT-2008 NO PROCESS
Japan Foods Co., Ltd.
Chosei-Gun , JP SAN-DO HG4-0011314-5/7/1
31KGT03 OOLONG TEA SOFT DRINK
10-OCT-2008 NO PROCESS
A.L.A. Corporation
Tokyo , JP SEA-DO 112-4584631-9/1/1
66VBY99 862713491575 DIETARY SUPPLEMENT SEIGEN
14-OCT-2008 DIRECTIONS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP BLT-DO HG4-0011316-0/1/1
31KGT03 OOLONG TEA SOFT DRINK
15-OCT-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP BLT-DO HG4-0011316-0/2/1
31KGT02 GREEN TEA SOFTDRINK
15-OCT-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP BLT-DO HG4-0011316-0/3/1
31KGT02 GREEN TEA SOFTDRINK
15-OCT-2008 NO PROCESS
Shinshin Food Cp., Ltd.
Tokyo , JP SAN-DO 597-0152318-1/3/5
25JGP21 Chilled Pickled Garlic (KSNS22)
16-OCT-2008 COLOR LBLG
Central Trading Co., Ltd.
Chuo-Ku JP-13, JP 104-0041 SAN-DO 597-0153336-2/7/1
25EGT99 JAPANESE PICKLES
16-OCT-2008 LACKS N/C
NUTRIT LBL
Shinko Co
Kitakyushu , JP LOS-DO HE8-0092231-3/1/1
29AGT06 NON CARBONATED SOFT DRINK-SIMPLE MINI SODA
16-OCT-2008 UNSAFE COL
NEEDS FCE
NO PROCESS
Shinko Co
Kitakyushu , JP LOS-DO HE8-0092231-3/1/2
29AGT06 NON CARBONATED SOFT DRINK-SHINKO DRINK
16-OCT-2008 NEEDS FCE
NO PROCESS
Shinko Co
Kitakyushu , JP LOS-DO HE8-0092231-3/1/3
29AGT06 NON CARBONATED SOFT DRINK-SIMPLE MINI SHINKO DRINK
16-OCT-2008 NEEDS FCE
NO PROCESS
Seiho Beverage Co.,Ltd.
Ukiha JP-40, JP 839-1333 LOS-DO HE8-0092231-3/1/4
29AGT99 NON CARBONATED SOFT DRINK-RYOKUCHA(GREEN TEA)
16-OCT-2008 NEEDS FCE
NO PROCESS
Seiho Beverage Co.,Ltd.
Ukiha JP-40, JP 839-1333 LOS-DO HE8-0092231-3/1/5
29AGT99 NON CARBONATED SOFT DRINK-OOLONG TEA
16-OCT-2008 NEEDS FCE
NO PROCESS
Miyama Meisui Co Ltd
Kyoto , JP LOS-DO HE8-0092231-3/1/6
29AGT99 NON CARBONATED SOFT DRINK-RYOKU CHA(GREEN TEA)
16-OCT-2008 NEEDS FCE
NO PROCESS
Miyama Meisui Co Ltd
Kyoto , JP LOS-DO HE8-0092231-3/1/7
29AGT99 NON CARBONATED SOFT DRINK-OOLONG TEA
16-OCT-2008 NEEDS FCE
NO PROCESS
Hanako Medical
Saitama City , JP FLA-DO FR1-0012433-3/1/1
80F--OZ CATHETER INTRODUCER FOR EXPORT ONLY
20-OCT-2008 NOT LISTED
Nipro Corporation
Osaka , JP FLA-DO FR1-0012433-3/2/1
78F--JI DIALYZERS FOR EXPORT ONLY
20-OCT-2008 NOT LISTED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667730-1/1/1
90I--YO HANDY PACHMETER !!! FOR EXPORT ONLY !!!
20-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667730-1/2/1
90I--YO BIOMETER 110V !!!! FOR EXPORT ONLY !!!!
20-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667730-1/3/1
86H--LM AUTO LENSMETER 110V !!!! FOR EXPORT ONLY !!!!
20-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667691-5/1/1
86H--JO SPECULAR MICROSCOPE !!!! FOR EXPORT ONLY !!!!
20-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667691-5/2/1
86H--JO ULTRASONIC A/B SCANNER !!! FOR EXPORT ONLY !!!
20-OCT-2008 REGISTERED
Nipro Corporation
Osaka , JP FLA-DO FR1-0012392-1/1/1
78F--JI DIALYZERS FOR EXPORT ONLY
20-OCT-2008 NOT LISTED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667762-4/1/1
86M--MQ TOPOGRAPHIC MODLING SYSTEM !!!! FOR EXPORT ONLY !!!!
22-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667762-4/2/1
90I--YO ULTRASONIC PACHYMETER !!!! FOR EXPORT ONLY !!!!
22-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667762-4/3/1
86H--JO SPECULA MICROSCOPE !!!! FOR EXPORT ONLY !!!!
22-OCT-2008 REGISTERED
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667762-4/4/1
90I--YO HANDY PACHMETER FOR EXPORT ONLY
22-OCT-2008 REGISTERED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010618-8/4/2
33SGE99 COLA LEMON CANDY
23-OCT-2008 UNSAFE COL
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010618-8/11/2
35AGN04 MUSCAT AND GRAPE GUMI
23-OCT-2008 UNSAFE COL
LIST INGRE
NUTRIT LBL
Ajinomoto Trading Inc
Tokyo , JP FLA-DO K51-0065018-0/1/1
86H--KY NON CONTACT TONOMETER
24-OCT-2008 REGISTERED
Ajinomoto Trading Inc
Tokyo , JP FLA-DO K51-0065018-0/1/5
86H--JO SLIT LAMP
24-OCT-2008 REGISTERED
Sato Pharmaceutical Co., Ltd
Tokyo , JP 107 LOS-DO 224-2719299-6/2/1
60GBY99 CLEANSING SOOTHING REFRESHING / LARYINGOAL SPRAY
26-OCT-2008 NOT LISTED
Sigma-Aldrich Japan Kk
Tokyo , JP 3111 CHI-DO 336-6727715-9/1/1
60CIY04 (+-)-EPINEPHRINE/ FOR LAB USE ONLY NOT A FOOD ADDITIVE
27-OCT-2008 NOT LISTED
UNAPPROVED
Kinjo Confectionery
Aichi , JP SAN-DO ANP-0010522-2/37/1H
35AGN04 konnyaku jelly (lychee)
27-OCT-2008 FILTHY
Kinjo Confectionery
Aichi , JP SAN-DO ANP-0010522-2/37/1G
35AGN04 nata de coco in konjac jelly (green apple)
27-OCT-2008 FILTHY
Kinjo Confectionery
Aichi , JP SAN-DO ANP-0010522-2/37/1F
35AGN04 nata de coco inkonnyako jelly (mango)
27-OCT-2008 FILTHY
Kinjo Confectionery
Aichi , JP SAN-DO ANP-0010522-2/37/1I
35AGN04 egg flavor (pudding)
27-OCT-2008 FILTHY
Sanuki Kanzume Co., Ltd.
Mitoyo-Gun , JP SEA-DO 112-4854588-4/5/1
24AEE16 CANNED BLACK BEANS
28-OCT-2008 NO PROCESS
JAPAN SANGARIA BEVERAGE CO., LTD. IMAGAWA - PLANT
OSAKA JP-27, JP 546-0003 NYK-DO N59-0162791-3/1/1
29YEI99 SOFT DRINKS-HACHIMITSU LEMON IN CAN
29-OCT-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP NYK-DO N59-0162791-3/2/1
29YEI99 SOFT DRINKS-TUBUMI MANGO IN CAN
29-OCT-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP NYK-DO N59-0162791-3/3/1
29YEI99 SOFT DRINKS-TUBUMI SHIROBUDOU IN CAN
29-OCT-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP NYK-DO N59-0162791-3/5/1
29YEI99 NATA DE COCO
29-OCT-2008 NO PROCESS
Arita Shokuhin Co,Ltd
Wakayama , JP 6490304 NYK-DO AX7-2038136-1/2/1
24EGT03 BEANS CURRY SAUCE
29-OCT-2008 NUTRIT LBL
Sunflek Nagatanien Co,Ltd
Hukusima , JP 9728312 NYK-DO AX7-2038136-1/5/1
25EGT99 CHINESE VEGETABLE
30-OCT-2008 NUTRIT LBL