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
Olympus Medical Systems Corp. Tokyo , JP FLA-DO 510-5466418-3/1/1 78K--OG ENDOSCOPIC SUBMUCOSAL DISSECTION TRAINING MODEL LM-083 01-APR-2008 NO 510(K) Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SAN-DO ANP-0009232-1/9/1 79M--XE ADHESIVE BANDAGE 01-APR-2008 NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/1/1 16AGC15 FRESH EEL 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/2/1 16AGT99 FRESH FISH ( TURBAN SHEL FISH ) 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/3/1 16AGT45 FRESH SKIPJACK 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/4/1 16MGC09 FRESH OCTUPUS 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/5/1 16AGC73 FRESH MACKEREL 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/6/1 16AGC80 FRESH SEABREAM 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/7/1 16AGT79 FRESH AMBERJACK 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/8/1 16AGC80 FRESH SEABREAM 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/9/1 16AGT70 FRESH SHAD 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/10/1 16AGT99 FRESH FISH ( ROCK SHELL FISH ) 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/11/1 16AGC73 FRESH MACKEREL 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/12/1 16MGD14 FRESH WHELK (SEA SNAILS) 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/13/1 16AGT33 FRESH SARDINES 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/14/1 16AGD36 FRESH SMELT 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/15/1 16MGT03 FRESH SQUID 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/16/1 16AGT12 FRESH COD 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/17/1 16AGT16 FRESH FLOUNDER 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/18/1 16AGC15 FRESH EEL 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/19/1 16AGT43 FRESH SEA BASS (SUZUKI) 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/20/1 04YCN99 UODON NOODLES 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/21/1 24TGC29 FRESH SEAWEED 03-APR-2008 INSANITARY NO ENGLISH Tamatetsu Tokyo , JP LOS-DO T09-0503582-7/22/1 16AGC15 FRESH EEL 03-APR-2008 INSANITARY NO ENGLISH Miyama Meisui Co Ltd Kyoto , JP LOS-DO HE8-0091531-7/1/2 29AGT06 SOFT DRINK-OOLONG TEA 10-APR-2008 NEEDS FCE Miyama Meisui Co Ltd Kyoto , JP LOS-DO HE8-0091531-7/1/1 29AGT06 SOFT DRINK-RYOKU CHA (GREEN TEA) 10-APR-2008 NEEDS FCE Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/1 80K--GX ADHESIVE PLASTERS 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/2 80K--GX TRANSPARENT FIRST AID PLASTER 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/3 80K--GX FABRIC ADHESIVE PLASTER 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/4 80K--GX WATERPROOF STRIPS 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/5 80K--GX ELASTIC STRIPS 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/1/6 80K--GX ADHESIVE BANDAGE 14-APR-2008 NOT LISTED DIRECTIONS NO ENGLISH Kaijin Boueki Inc Tokyo , JP LOS-DO EML-0100061-5/7/1 25JGD24 PICKLED GINGER 14-APR-2008 UNSAFE COL Haba Laboratories Inc Tokyo , JP LOS-DO DO7-1106227-6/10/1 66PBJ99 UV CUT MILK 14-APR-2008 UNAPPROVED MITSUYA CO.,LTD ASAKITAKU JP-34, JP 731-0223 SEA-DO ANP-0009371-7/12/1 23BEE04 SWEET BROILED CHESTNUTS 100G 15-APR-2008 NEEDS FCE NO PROCESS Bestplanet Iyo-shi JP-38, JP 7993105 SEA-DO ANP-0009371-7/74/1 16LGH05 GROCERIES DRIED SMALL SHRIMP 15-APR-2008 UNSAFE COL FALSE NO ENGLISH Takagi Seiko Ltd. Nagano City , JP 383 FLA-DO DM9-7011485-4/1/2 86H--KY TONOMETER 15-APR-2008 NOT LISTED NO 510(K) Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO AJR-7266470-7/4/1A 53LY-99 3D-DEEP BOTOLIUM Transdermal Facial Gel for Visible Wrinkle 15-APR-2008 NO ENGLISH UNAPPROVED Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO AJR-7266470-7/4/1B 53LY-99 3D-DEEP BOTOLIUM Under-Eye Treatment Transdermal Under-Eye M 15-APR-2008 UNAPPROVED Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO AJR-7266470-7/6/1 53LY-99 3D- Deep Botolium D-Trans-System Extra Deeper Formula 15-APR-2008 UNAPPROVED Kanto Nosan Inc. Ibaraki , JP 300 0422 NYK-DO G75-1037025-5/2/1 25JGI07 PICKLED RADISH 16-APR-2008 NEEDS ACID Eiwa Shoji Co. Ltd. Tokyo , JP 104-0045 SAN-DO 304-0192219-7/2/1 25JGP24 Pickled Ginger (per invoice) 18-APR-2008 UNSAFE COL Mitsubishi Corp Tokyo , JP 215-9808 LOS-DO 286-3509956-8/1/1 66VAR99 Pharma Gaba 80 19-APR-2008 NOT LISTED UNAPPROVED Sennari Co Hiroshima , JP SEA-DO ANP-0009485-5/9/2 37JGE08 TONKATSU SAUCE 22-APR-2008 LIST INGRE UNSAFE ADD Sennari Co Hiroshima , JP SEA-DO ANP-0009485-5/9/3 37JGE08 TYUUNOU SAUCE 22-APR-2008 UNSAFE ADD Sennari Co Hiroshima , JP SEA-DO ANP-0009485-5/9/4 37JGE08 USUTA SAUCE 22-APR-2008 UNSAFE ADD FALSE Sennari Co Hiroshima , JP SEA-DO ANP-0009485-5/9/5 37JGE08 YAKISOBA SAUCE 22-APR-2008 LIST INGRE UNSAFE ADD Sennari Co Hiroshima , JP SEA-DO ANP-0009485-5/11/1 37JGE08 HAMBARG SAUCE 22-APR-2008 FALSE NEEDS FCE NO PROCESS Sangaria Osakashi , JP SEA-DO ANP-0009533-2/12/2 25GHE99 BEJILIFE YASAI TO FRUIT 500 22-APR-2008 NEEDS FCE NO PROCESS Chemo Sero Therapeutic Research Kumamoto , JP SAN-DO 112-1962732-3/1/1 56DDY79 859961258700 STREPTOMYCIN SULFATE 22-APR-2008 NOT LISTED Kabaya Co., Ltd. Okayama-shi JP-33, JP 7092196 SEA-DO ANP-0009199-2/16/1C 35AGN04 Zerry Egg Flavor Jelly Pudding 22-APR-2008 LIST INGRE Kabaya Co., Ltd. Okayama-shi JP-33, JP 7092196 SEA-DO ANP-0009199-2/16/1B 35AGN04 Zerry Nata De Coco in Konjac Jelly 22-APR-2008 FALSE Sankohen Shoten Oroshibu Tokyo , JP 116 0009 SEA-DO ANP-0009199-2/1/1 36CCT04 ACACIA HONEY 22-APR-2008 FALSE USUAL NAME Tokai Hyogo K.K. Nagoya , JP SEA-DO ANP-0009199-2/8/6 33SGE99 FRUITS CANDY 22-APR-2008 LIST INGRE NUTRIT LBL Tokai Hyogo K.K. Nagoya , JP SEA-DO ANP-0009199-2/8/8 33SGE99 MUSCAT CANDY 22-APR-2008 UNSAFE COL LIST INGRE NUTRIT LBL Kabaya Co., Ltd. Okayama-shi JP-33, JP 7092196 SEA-DO ANP-0009199-2/16/1A 35AGN04 MUSCAT GRAPE GUMI 22-APR-2008 UNSAFE COL LIST INGRE NUTRIT LBL Kabaya Co., Ltd. Okayama-shi JP-33, JP 7092196 SEA-DO ANP-0009199-2/87/1 33SGE99 3 PIECES JUC 22-APR-2008 UNSAFE COL LIST INGRE NUTRIT LBL SB Shokuhin K.K. Ueda Kojyo Ueda-shi JP-20, JP 386-0043 SAN-DO 597-0151574-0/28/1 25JGP24 GINGER PASTE 24-APR-2008 UNSAFE COL NUTRIT LBL Hisamitsu Pharmaceutical Co., Inc. Saga, Tosu , JP 841-0017 CHI-DO 805-0069477-5/9/1 66VAY99 RELIEVING PAIN PATCH 25-APR-2008 NOT LISTED Ogura Shokuhin Co., Ltd. Yui Cho Shizuoka Pref, JP SAN-DO D11-0114346-3/1/2 16AGT12 SEASONED COD FISH (77) 28-APR-2008 LIST INGRE COLOR LBLG LACKS FIRM LACKS N/C USUAL NAME Marui Suzuki Co Ltd Tokyo , JP SAN-DO D11-0114346-3/8/5 35AGT03 AGAR AGAR DESSERT (67) 28-APR-2008 COLOR LBLG Nipro Corporation Osaka , JP FLA-DO FR1-0012211-3/1/1 80F--OZ CATHETER INTRODUCER FOR EXPORT ONLY 29-APR-2008 REGISTERED NO 510(K)