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
Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0008987-1/1/1B 66VAY99 TITANIUM PATCHES 03-MAR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0008993-9/353/1 76E--FW DENTAL ERASER AND TOOTHBRUSHES LINE 352 03-MAR-2008 NOT LISTED Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009117-4/15/1A 53DD-02 Cool Sheet 03-MAR-2008 CSTIC LBLG LABELING Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009117-4/15/1D 80F--QM Cool Sheet 03-MAR-2008 DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009117-4/15/1F 80F--QM Face care sheet 03-MAR-2008 DIRECTIONS NO ENGLISH Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009313-9/2/1A 31KEI02 GREEN TEA 04-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009313-9/2/2 31KEI02 GREEN TEA WITH BROWN RICE 04-MAR-2008 NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009313-9/15/1 20BEE04 SWEET BROILED CHESTNUT 04-MAR-2008 NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009148-9/63/1 23CHE04 CHESTNUTS 04-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009148-9/71/1 31KEI02 GREEN TEA PET BOTTLE 04-MAR-2008 NEEDS FCE NO PROCESS Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009148-9/153/1 77J--YH SOFT EARPICK 04-MAR-2008 NOT LISTED Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009148-9/178/1A 80F--OR Antibacterial ear-pic cotton swabs 04-MAR-2008 NOT LISTED NO ENGLISH Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0008775-0/17/1A 31KET02 GREEN TEA DRINK 04-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0008775-0/17/1B 31KHT02 GREEN TEA PEP BOTTLE 04-MAR-2008 NEEDS FCE NO PROCESS Confex Co. Tokyo , JP 176-0014 SEA-DO ANP-0008775-0/18/1A 33SGE99 SEA TANGLE CANDY 04-MAR-2008 INCONSPICU USUAL NAME NUTRIT LBL Confex Co. Tokyo , JP 176-0014 SEA-DO ANP-0008775-0/18/1B 33CGT05 Rice Cake Stuffed Strawberry Candy 04-MAR-2008 UNSAFE COL LIST INGRE USUAL NAME ALLERGEN NUTRIT LBL KIMURA TUKEMONO MIYAZAKI CO.,LTD GOTOU GUN JP-45, JP 889-1403 SAN-DO 427-7302620-0/10/8 25JDT07 Seasoned Radish 07-MAR-2008 UNSAFE COL LIST INGRE YELLOW #5 Nara Seiko Inc Sakurai-Shi N , JP NOL-DO 112-7789134-6/1/1 87H--WC 850110787159-SCREW 07-MAR-2008 NOT LISTED NO 510(K) Daito Kasei Kogyo Co Ltd Osaka , JP 535 NOL-DO 112-8814121-3/1/1 53PD-99 859955321994 NFCB-3D-1R (Raw Material for Cosmetics) 07-MAR-2008 COLOR LBLG Takara Belmont Co Ltd Osaka , JP 530 FLA-DO DM9-8010094-3/1/1 76K--LC HYDRAULIC DOCTOR STOOL FOR EXPORT ONLY REG#9611445 10-MAR-2008 NOT LISTED Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009158-8/7/1 37JME99 BASE OF THE VEGETABLE RICE 14-MAR-2008 LIST INGRE USUAL NAME NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009158-8/8/1 23BEE04 SWEET BROILED CHESTNUT 14-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009158-8/12/1 37JME07 BASE OF THE HAMBURG 14-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009156-2/7/1 02DGE99 RETORT POUCH RICE 14-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009156-2/8/1 02DGE99 SEKIHAN 14-MAR-2008 NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009156-2/24/1A 07BGN99 KOSHIAN 14-MAR-2008 NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009156-2/24/1B 07BGN99 Tubuan 14-MAR-2008 NEEDS FCE NO PROCESS Kinjouseika Aichi , JP 440-0856 SEA-DO ANP-0009156-2/29/1 35AGN04 KONNYAKU JELLY 14-MAR-2008 FOREIGN OB LABELING Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009156-2/38/1 31KEE02 GREEN TEA DRINK 14-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009156-2/42/1 31KEE03 OOLONG TEA DRINK 14-MAR-2008 NEEDS FCE NO PROCESS Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009156-2/43/1 31KHE02 GREEN TEA PET BOTTLE 14-MAR-2008 NEEDS FCE NO PROCESS Ace Bakery Co Ltd Komaki , JP Aichi Pref SAN-DO 427-7301132-7/4/6 03NDT01 Cheese Cake 14-MAR-2008 LIST INGRE NUTRIT LBL Gunze Osaka -Shi , JP 5300001 NOL-DO 112-1717547-3/1/1 79G--AO 863384227385/NON-STERILE SUTURES 17-MAR-2008 NOT LISTED Nozaki Tsukemono Co Ltd Miyazaki , JP SAN-DO 221-2534888-2/14/3 25JGT07 PREPARED RADISH 17-MAR-2008 YELLOW #5 SENNARI CO.,LTD. HIROSHIMASHI JP-34, JP 731-3362 SAN-DO ANP-0009200-8/3/1 37JGE08 BASE OF THE HAMBURG 18-MAR-2008 NEEDS FCE NO PROCESS MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009489-7/7/1 23BEE04 CHESTNUT 18-MAR-2008 NEEDS FCE NO PROCESS SENNARI CO.,LTD. HIROSHIMASHI JP-34, JP 731-3362 SEA-DO ANP-0009489-7/10/1 37JGE08 TAKOYAKI SAUCE 18-MAR-2008 UNSAFE ADD LABELING SENNARI CO.,LTD. HIROSHIMASHI JP-34, JP 731-3362 SEA-DO ANP-0009489-7/10/2 37JGE08 TYUUNOU SAUCE 18-MAR-2008 UNSAFE ADD USUAL NAME SENNARI CO.,LTD. HIROSHIMASHI JP-34, JP 731-3362 SEA-DO ANP-0009489-7/11/1 37JGE08 HAMBARG SAUCE 18-MAR-2008 NEEDS FCE NO PROCESS Sunstar Inc. Takatsuki, Osaka , JP 569-1195 CHI-DO 610-3219967-3/3/1 25MYY01 CARROT MIX JUICE 19-MAR-2008 NO PROCESS Sunstar Inc. Takatsuki, Osaka , JP 569-1195 CHI-DO 610-3219967-3/4/1 25JYY12 SWEET POTATO AND FRUIT MIX JUICE 19-MAR-2008 NEEDS FCE NO PROCESS Mitisubishi Tanabe Pharma Corp Osaka , JP 5418505 LOS-DO AEK-7964548-3/1/1 66VCY99 O-ACETYL-L-CARNITINE CHLORIDE(HARMLESS CHEMICALS) 19-MAR-2008 NOT LISTED UNAPPROVED Clay Science Tokyo , JP LOS-DO K64-0649267-3/1/1 66VBL99 B.GLEN NATURAL CLAY SUNSCREEN 25 19-MAR-2008 NOT LISTED DRUG NAME Matsushita Electric Industrial Co Ltd Osaka Osaka, JP 542 FLA-DO 406-0413354-2/1/1 94R--BB DIGITAL STILL CAMERA - FOR EXPORT ONLY 27-MAR-2008 NON STD Ebara Foods Industry Co., Ltd. Tsuyama Plant Tsuyama City, Okayama , JP LOS-DO 221-1882196-0/4/1 37JCT99 SEASONING SOY SAUCE (SUKIYAKI NO TARE) 27-MAR-2008 NEEDS FCE NO PROCESS Ebara Foods Industry Co., Ltd. Tsuyama Plant Tsuyama City, Okayama , JP LOS-DO 221-1882196-0/6/1 37JCT99 SEASONING SAUCE FOR SUKIYAKI (MILD) 27-MAR-2008 NEEDS FCE NO PROCESS