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
Matsushita Electric Industrial Co Ltd
Osaka Osaka, JP 542 FLA-DO 406-0418021-2/2/1
95R--FW DVD PLAYER - FOR EXPORT ONLY
02-JUL-2008 NON STD
Fujikougyo Co.,Ltd
Anjyo Cityaichi , JP 444-1163 LOS-DO HE8-0092231-3/2/5
29BGT99 CARBONATED SOFT DRINK-RAMUNE DRINK MIKAN
09-JUL-2008 UNSAFE COL
Fujikougyo Co.,Ltd
Anjyo Cityaichi , JP 444-1163 LOS-DO HE8-0092231-3/2/4
29BGT99 CARBONATED SOFT DRINK-RAMUNE DRINK MELON
09-JUL-2008 UNSAFE COL
Fujikougyo Co.,Ltd
Anjyo Cityaichi , JP 444-1163 LOS-DO HE8-0092231-3/2/3
29BGT99 CARBONATED SOFT DRINK-RAMUNE DRINK STRAWBERRY
09-JUL-2008 UNSAFE COL
Fujikougyo Co.,Ltd
Anjyo Cityaichi , JP 444-1163 LOS-DO HE8-0092231-3/2/2
29BGT99 CARBONATED SOFT DRINK-RAMUNE DRINK BLUE HAWAII
09-JUL-2008 UNSAFE COL
Fujikougyo Co.,Ltd
Anjyo Cityaichi , JP 444-1163 LOS-DO HE8-0092231-3/2/1
29BGT99 CARBONATED SOFT DRINK-RAMUNE DRINK MANGO
09-JUL-2008 UNSAFE COL
Satoru Yoshino
Tokyo , JP LOS-DO AEK-9677686-5/1/1
60LBJ99 COSMETICS
14-JUL-2008 NOT LISTED
UNAPPROVED
Kagome Inc, Nasu Plant
Tochigi , JP LOS-DO 221-1889200-3/35/1
37JET08 LIQUID PASTA SAUCE
15-JUL-2008 NEEDS FCE
NO PROCESS
Toasu Co., Ltd.
Aichi Pref , JP LOS-DO HG4-0009406-3/1/1
29AET07 TUBUMI MANGO 280ML
17-JUL-2008 NEEDS FCE
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009406-3/4/1
31KGT03 OOLONG TEA 500ML PET SOFT DRINK
17-JUL-2008 NEEDS FCE
Japan Sangaria Beverage Co., Ltd.Iga Factory
Mie, 519-1404 , JP LOS-DO HG4-0009406-3/5/1
31KGT02 GREEN TEA SOFTDRINK 500ML PET
17-JUL-2008 NEEDS FCE
Shinshan Foods Co. Ltd
Gunma , JP 379 2143 SEA-DO U47-0460551-6/30/1
24FGN20 PICKLED CUCUMBER
21-JUL-2008 UNSAFE COL
LIST INGRE
Shin Shin Co
Gunma , JP SEA-DO U47-0460551-6/34/1
24FGE20 SALTED CUCUMBER
21-JUL-2008 UNSAFE COL
LIST INGRE
Shin Shin Co
Gunma , JP SEA-DO U47-0460551-6/35/1
24FGN20 PICKLED CUCUMBER
21-JUL-2008 UNSAFE COL
LIST INGRE
Shin Shin Co
Gunma , JP SEA-DO U47-0460551-6/40/1
25JGP07 PICKLED RADISH
21-JUL-2008 YELLOW #5
Kyushu Nousan Co., Ltd.
Kagoshima , JP SEA-DO U47-0460551-6/41/1
25JGP07 SALTED RADISH
21-JUL-2008 YELLOW #5
Taiyo Tsukemono Co Ltd
Fukagawa Aza Soo County Kagoashima Pref, JP SEA-DO U47-0460551-6/42/1
25JGP07 SALTED RADISH
21-JUL-2008 YELLOW #5
NANAO Confectionery Co., Ltd.
Kitakyushu JP-40, JP 8000297 SEA-DO U47-0460551-6/77/1
33LHE14 FRUITES FLAVOR JELLY
21-JUL-2008 UNSAFE COL
LABELING
Nipro Corporation
Osaka , JP FLA-DO FR1-0012313-7/1/1
79K--GX PUSHBAN FOR EXPORT ONLY
22-JUL-2008 NOT LISTED
NO 510(K)
Nipro Corporation
Osaka , JP FLA-DO FR1-0012313-7/2/1
78F--JI DIALYZERS FOR EXPORT ONLY
22-JUL-2008 NOT LISTED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/1/1
86H--JB TOPOGRAPHIC MODELING SYSTEM
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/2/1
86H--JB BIO & PACHYMETER
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/3/1
86H--JB AUTO LENSMETER
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/4/1
86H--JB AUTO LENSMETER
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/5/1
86H--JB AUTO LENSMETER
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Tomey Corporation
Nagoya -Shi , JP 4510051 FLA-DO 286-0667339-1/6/1
86H--JB ULTRASONIC A/B SCANNER FOR EXPORT ONLY
22-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/16/1
79E--FQ EMERGENCY PLASTER
23-JUL-2008 NOT LISTED
NO 510(K)
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/16/2
79E--FQ FOLD GAUZE
23-JUL-2008 NOT LISTED
NO 510(K)
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/53/1
89I--QI FAR INFRARED SUPPORTER
23-JUL-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/16/3
79E--FQ WOUND APPLICATION GAUZE
23-JUL-2008 NOT LISTED
NO 510(K)
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/53/2
89I--QI SUPPORT TYPE
23-JUL-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/53/3
89I--QI TREE SAP SHEET W CHILI PEPPER
23-JUL-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/54/1
89I--TQ FAR INFRARED SUPPORTER
23-JUL-2008 NOT LISTED
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SAN-DO ANP-0010141-1/54/2
89I--TQ SUPPORT TYPE
23-JUL-2008 NOT LISTED
Yaman Ltd.
Tokyo , JP 135 SAN-DO K80-7044485-7/1/1
89N--ZF SLIM FACE - FACIAL MASSAGER
23-JUL-2008 NOT LISTED
REGISTERED
NO 510(K)
Nozaki Tsukemono Co Ltd
Miyazaki , JP LOS-DO 221-1891278-5/65/14
25JGP26 PICKLED RADISH (YAGURASHIBORIKATSUO) Item# 4197
24-JUL-2008 UNSAFE ADD
Nozaki Tsukemono Co Ltd
Miyazaki , JP LOS-DO 221-1891278-5/65/15
25JGP26 PICKLED RADISH (YAGURASHIBORIKONBU) Item# 4198
24-JUL-2008 UNSAFE ADD
Nozaki Tsukemono Co Ltd
Miyazaki , JP LOS-DO 221-1891278-5/65/16
25JGP26 PICKLED RADISH (YAGURASHIBORIUME) Item# 4199
24-JUL-2008 UNSAFE ADD
Nozaki Tsukemono Co Ltd
Miyazaki , JP LOS-DO 221-1891278-5/65/17
25JGP26 PICKLED RADISH (HONBOSHINUKAZUKE) Item# 4200
24-JUL-2008 UNSAFE ADD
Parylene Japan K.K.
Tokyotokyo , JP 1920012 CHI-DO EE6-7133588-7/1/1
74M--AF STENT, CARDIOVASCULAR;;
25-JUL-2008 NO PMA
Parylene Japan K.K.
Tokyotokyo , JP 1920012 CHI-DO EE6-7133823-8/1/1
74M--AF STENT, CARDIOVASCULAR;;
25-JUL-2008 NO PMA
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/1
62KCA10 OMEPRAZOLE/NO RX/NO ID/PER USE
30-JUL-2008 UNAPPROVED
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/6
66VCA99 G'DAY HEALTH/NO ID/PER USE/LOOSE PILLS IN BAG NO DESCRIPTION
30-JUL-2008 UNAPPROVED
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/7
66VCA99 SUKKUL/NO RX/NO ID/PER USE
30-JUL-2008 UNAPPROVED
Yamajin Co., Ltd
Oita , JP SAN-DO 597-0153265-3/1/3
16AGH33 FROZEN DRIED SARDINE
30-JUL-2008 INSANITARY
Marutomo Co., Ltd Child Iyo Plant
Iyo City, Ehime , JP SAN-DO 427-7305510-0/9/1
16MHT07 SEASONED CUTTLEFISH
31-JUL-2008 LISTERIA
Marutomo Co., Ltd Child Iyo Plant
Iyo City, Ehime , JP SAN-DO 427-7305510-0/9/2
16MHT07 FROZEN SEASONED CUTTLEFISH
31-JUL-2008 LISTERIA