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
NIPPON MEAT PACKERS, INC., R&D CENTER
TSUKUBA JP-08, JP 300-2646 SAN-DO 112-2545453-0/1/1
88L--DT 860771147467 LAB REAGENT/MILK DETECTION
02-JUN-2008 NOT LISTED
REGISTERED
Pioneer International Latin American S.A
Panama , PA 5 FLA-DO BJM-0110419-1/6/1
95L--32 AVH-P4950DVD AV/DVD MONITOR UNIT (FOR EXPORT ONLY)
03-JUN-2008 NON STD
KATO BROTHERS HONEY CO.,LTD.YOKOHAMA PLANTS
YOKOHAMA JP-14, JP 236-0004 SAN-DO 597-0152140-9/2/1
36CHT04 HONEY (PLASTIC BTL)
05-JUN-2008 NUTRIT LBL
Toko Shoji Co
Yokohama , JP LOS-DO 905-3369297-7/9/9
29AGS06 SOKENBI BRAND SOFT DRINKS
05-JUN-2008 NEEDS FCE
NO PROCESS
SHINSHIN CO., LTD.
MAEBASHI-SHI JP-10, JP 379-2143 CHI-DO 677-0319637-7/93/1
25JGP07 PICKLED RADISH
09-JUN-2008 UNSAFE COL
COLOR LBLG
SHINSHIN CO., LTD.
MAEBASHI-SHI JP-10, JP 379-2143 CHI-DO 677-0319637-7/95/1
25JGP07 PICKLED RADISH
09-JUN-2008 UNSAFE COL
COLOR LBLG
Tokai Tsukemono Seizo Co Ltd
Toyohashi Aichi, JP CHI-DO 677-0319637-7/101/1
25JGP24 PICKLED GINGER
09-JUN-2008 UNSAFE COL
COLOR LBLG
ONSUI CO., LTD EHIME FACTORY
UWAJIMA-SHI JP-38, JP 798-0104 NYK-DO K64-0216083-7/2/1
16AVT79 Cold smoked yellowtail loin
10-JUN-2008 FILTHY
Toasu Co., Ltd.
Aichi Pref , JP SEA-DO 221-4020714-7/1/1
29AEI08 SOFT DRINK, VINE FRUIT FLAVORED, NONCARBONATED;METAL;PACKAGE
10-JUN-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP SEA-DO 221-4020714-7/1/2
29AEI07 SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBO
10-JUN-2008 NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP SEA-DO 221-4020714-7/3/1
29AEI70 SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBON
10-JUN-2008 NO PROCESS
WAKABATO SEIKA CO.,LTD
NAGOYA JP-23, JP 4550874 SAN-DO 427-7304022-7/1/6
03FDT02 CRACKER
10-JUN-2008 UNSAFE COL
WAKABATO SEIKA CO.,LTD
NAGOYA JP-23, JP 4550874 SAN-DO 427-7304022-7/1/7
03FDT02 CRACKER
10-JUN-2008 UNSAFE COL
Em Corporation
Okinawa , JP LOS-DO M17-0040571-9/1/1
41BGT99 FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ART
11-JUN-2008 NEEDS FCE
NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/1/1
29AET02 HACHIMITSU LEMON 900ML NON-CARB. SOFT DRINK
17-JUN-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/2/1
25GGT99 URESHII RYOKUOU YASAI 900ML
17-JUN-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/3/1
24JET50 URESHII TOMATO 900ML
17-JUN-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/4/1
25GET99 URESHI YASAI FRUIT 900ML
17-JUN-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/5/1
31KGT02 GREEN TEA SOFTDRINK 500ML
17-JUN-2008 NO PROCESS
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009727-2/6/1
31KGT02 GREEN TEA SOFTDRINK 2000ML
17-JUN-2008 NO PROCESS
Nipro Corporation
Osaka , JP FLA-DO FR1-0012278-2/1/1
78F--KP DIALYSIS MACHINE FOR EXPORT ONLY
18-JUN-2008 REGISTERED
Shimada Shozi Co Ltd
Tochigi , JP NYK-DO 481-0153822-0/16/1
25JHP24 GINGER IN BRINE
19-JUN-2008 UNSAFE COL
Taiyoutsukemono Corporation
Kagosima , JP NYK-DO 481-0153822-0/67/1
25JGP07 PICKLED RADISH
19-JUN-2008 UNSAFE COL
Keiko Suzuki
*Shizuoka*Shizuoka , JP 4380817 CIN-DO UPS-1205796-2/1/1
64GDB07 ORAL CONTRACEPTIVE, NO RX, NO ID, PER USE
23-JUN-2008 UNAPPROVED
Mamma Riso Co LTD
Fukuoka JP-40, JP 813-0062 LOS-DO HG4-0009698-5/1/1
72BGB05 Natural Homemade Food for Dogs (Chicken)
23-JUN-2008 NEEDS FCE
Mamma Riso Co LTD
Fukuoka JP-40, JP 813-0062 LOS-DO HG4-0009698-5/2/1
72BGB05 Natural Homemade Food For Dogs (Salmon)
23-JUN-2008 NEEDS FCE
Mamma Riso Co LTD
Fukuoka JP-40, JP 813-0062 LOS-DO HG4-0009698-5/3/1
72BGB05 Natural Homemade Food For Dogs (Horse)
23-JUN-2008 NEEDS FCE
Mamma Riso Co LTD
Fukuoka JP-40, JP 813-0062 LOS-DO HG4-0009698-5/4/1
72BGB05 Natural Homemade Food For Dogs (Sardine)
23-JUN-2008 NEEDS FCE
Ajirushi Suisan Co. Ltd.
Ibaraki Ibaragi, JP 311-12 CHI-DO 510-1373238-6/8/1
16MGT03 FROZEN SEASONED OCTOPUS (SHUKA TAKO SANSAI)
24-JUN-2008 LISTERIA
SB Shokuhin K.K. Ueda Kojyo
Ueda-shi JP-20, JP 386-0043 LOS-DO 221-1888192-3/28/1
37JEE08 LIQUID PASTA SAUCE
27-JUN-2008 NEEDS FCE
NO PROCESS
SB Shokuhin K.K. Ueda Kojyo
Ueda-shi JP-20, JP 386-0043 LOS-DO 221-1888192-3/29/1
37JHE08 LIQUID TOMATO SAUCE
27-JUN-2008 NEEDS FCE
NO PROCESS
SB Shokuhin K.K. Ueda Kojyo
Ueda-shi JP-20, JP 386-0043 LOS-DO 221-1888192-3/29/2
37JHE08 LIQUID PASTA SAUCE ( TOMATO)
27-JUN-2008 NEEDS FCE
NO PROCESS
SB Shokuhin K.K. Ueda Kojyo
Ueda-shi JP-20, JP 386-0043 LOS-DO 221-1888192-3/30/1
16YGE17 LIQUID PASTA SAUCE
27-JUN-2008 NEEDS FCE
NO PROCESS
SB Shokuhin K.K. Ueda Kojyo
Ueda-shi JP-20, JP 386-0043 LOS-DO 221-1888192-3/31/1
37JHE08 LIQUID PASTA SAUCE (TOMATO)
27-JUN-2008 NEEDS FCE
NO PROCESS
8 Knot Co Ltd
Osaka , JP SEA-DO 322-2553782-1/1/1
66VBY99 BOTTLED WATER
30-JUN-2008 LABELING
UNAPPROVED