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
JYUICHIYA CO.,LTD Tokyo JP-13, JP 1040045 LOS-DO AX4-0044125-3/5/4 25JGP07 PICKLED RADISH 01-NOV-2007 UNSAFE COL Ajirushi Suisan Co. Ltd. Ibaraki Ibaragi, JP 311-12 SAN-DO 221-2535523-4/10/3 16MGT09 FROZEN SEASONED OCTOPUS 02-NOV-2007 LISTERIA Yamamori Co Ltd Matsuzaka-Shi Mie Pref , JP BLT-DO BMT-0019349-7/28/1 28KGT99 SEASONING 06-NOV-2007 NO ENGLISH NO PROCESS Chielin Co Ltd Osaka , JP BLT-DO BMT-0019349-7/111/1 33UGT02 CHEWING GUM 06-NOV-2007 UNSAFE COL NO ENGLISH Kirin Beverage Co., Ltd Takaza-Gun, Kanagawa , JP 253-0101 BLT-DO BMT-0019349-7/132/1 29AGT99 SOFT DRINK 06-NOV-2007 NO ENGLISH NO PROCESS Kirin Beverage Co., Ltd Takaza-Gun, Kanagawa , JP 253-0101 BLT-DO BMT-0019349-7/134/1 29AGT99 SOFT DRINK 06-NOV-2007 NO ENGLISH NO PROCESS Daison Industries Co Ltd Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008552-3/9/1 02DYE99 RETORT POUCH RICE 07-NOV-2007 NEEDS FCE NO PROCESS Daison Industries Co Ltd Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008552-3/253/1 76E--FW TOOTHBRUSH 07-NOV-2007 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0666258-4/5/1 86H--JB ULTRASONIC PACHYMETER 08-NOV-2007 REGISTERED NO 510(K) Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0666258-4/1/1 86H--JB ULTRASONIC PACHYMETER 08-NOV-2007 REGISTERED NO 510(K) Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0666258-4/2/1 86H--JB AUTO LENSMETER 08-NOV-2007 REGISTERED NO 510(K) Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0666258-4/3/1 86H--JB BIOMETER 110V 08-NOV-2007 REGISTERED NO 510(K) Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0666258-4/4/1 86H--JB HANDY PACHMETER FOR EXPORT ONLY 08-NOV-2007 REGISTERED NO 510(K) Shigemitsu Sangyo K.K. Kumanoto City , JP LOS-DO CEA-0033121-0/14/1 38MEN33 MISO 13-NOV-2007 LIST INGRE NUTRIT LBL NEEDS FCE NO PROCESS Fuji Merchandise Inc. Yokohama , JP 2310007 LOS-DO 638-0087681-3/1/1 76E--FW TOOTHBRUSH 13-NOV-2007 REGISTERED Bean Stalk Snow Co.,Ltd. Tokyo JP-13, JP 160-0003 SAN-DO 427-1190019-3/2/3 37BGT99 FISH & VEGETABLE PORRIDGE SHIRASU TARA YASAI GAYU 14-NOV-2007 NEEDS FCE NO PROCESS Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SAN-DO ANP-0007709-0/6/1A 07BGN99 shrimp flavored rice cracker 14-NOV-2007 UNSAFE COL LIST INGRE O'will Corporation Tokyo JP-13, JP 1020093 NYK-DO 791-4378178-3/1/1 66VCY99 NIVEA BODY GOODBYE CELLULITE PATCH 15-NOV-2007 UNAPPROVED Kikkoman Co. Ltd. Tokyo , JP SAN-DO 597-0148853-4/24/1 25PGT04 PREP MUSHROOM 17-NOV-2007 NEEDS FCE NO PROCESS Mitsukan Co Ltd Aichi , JP SAN-DO 597-0148853-4/25/1 25JGT26 PREP RADISH W/CHILI PEPPER 17-NOV-2007 NEEDS FCE NO PROCESS Momoya K K Tokyo , JP SAN-DO 597-0148853-4/34/10 37JCT03 CHILI SAUCE 17-NOV-2007 NEEDS FCE NO PROCESS Bulldog Sauce Co. Ltd. Tokyo , JP 103 SAN-DO 597-0149835-0/14/1 37JHI99 SEASONED SAUCE 19-NOV-2007 NEEDS FCE NO PROCESS Nanshin Tsukemono Co., Ltd. Iida City Nagano Pref, JP SAN-DO 427-2300600-5/3/1 25NGT22 COOKED BURDOCK 27-NOV-2007 NEEDS FCE NO PROCESS Topcon Corporation Tokyo , JP 174 FLA-DO 554-3461592-2/1/1 86N--QE MICROSCOPE, SPECULAR;; 27-NOV-2007 NOT LISTED REGISTERED NO 510(K) Nippon Del Monte Corporation Numata-City, Gunma , JP 3780016 NYK-DO 554-5297952-3/10/1 25ECO99 VEGETABEL & FRUIT MIX JUICE (CARROT, SPINACH, PARSLEY, LEMON 29-NOV-2007 NEEDS FCE NO PROCESS Leo D'Or Trading Co Ltd Tokyo , JP 103 ATL-DO EE6-1339917-3/4/1 53LF-01 HERBAL WRAP/PAD FOR SKIN CARE/CLEANSING 30-NOV-2007 UNAPPROVED