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
Maruwa Watanabe Suisan Co., Ltd Hyogo , JP BLT-DO 113-4329830-0/63/1 24TGT29 SEASONED SEAWEED 05-AUG-2008 NO PROCESS Momoya Co., Ltd. Kasukabe Saitama, Japan , JP BLT-DO 113-4329830-0/64/1 24TGT29 SEASONED SEAWEED 05-AUG-2008 NO PROCESS Nipro Corporation Osaka , JP SEA-DO 112-3610235-9/1/1 74O--FM 841940208030 BLOOD COLLECTION KIT 05-AUG-2008 NOT LISTED NO 510(K) Nihon Vitamin Chemical Co Ltd Toyama , JP CIN-DO AEK-9541121-7/1/1 41YCY99 RED SUN LIN ZHI 200MG (DIETARY SUPPLEMENTS) 06-AUG-2008 UNAPPROVED Nihon Vitamin Chemical Co Ltd Toyama , JP CIN-DO AEK-9541132-4/1/1 41YCY99 RED SUN LING ZHI 200MG (DIETARY SUPPLEMENTS) 06-AUG-2008 UNAPPROVED JAPAN SANGARIA BEVERAGE CO., LTD. IMAGAWA - PLANT OSAKA JP-27, JP 546-0003 NYK-DO N59-0161376-4/1/1 29YHF99 SOFT DRINKS AND FLV WATERS- HACHIMITSU LEMON 06-AUG-2008 NO PROCESS Japan Sangaria Beverage Co., Ltd Osaka , JP 546 NYK-DO N59-0161376-4/6/1 29YHF99 SOFT DRINKS FLV WATERS -URESHII YASAI FRUIT 06-AUG-2008 NO PROCESS Toasu Co., Ltd. Aichi Pref , JP NYK-DO N59-0161376-4/2/1 29YHF99 SOFT DRINKS AND FLV WATERS- TUBUMI MANGO 06-AUG-2008 NO PROCESS Toasu Co., Ltd. Aichi Pref , JP NYK-DO N59-0161376-4/3/1 29YHF99 SOFT DRINKS AND FLV WATERS-TUBUMI SHIROBUDOU 06-AUG-2008 NO PROCESS Toasu Co., Ltd. Aichi Pref , JP NYK-DO N59-0161376-4/5/1 29YCI99 MILK BASED SOFT DRINKS WATERS NOT MENTIONED ELSEWHERE, N.E.C 06-AUG-2008 NO PROCESS Eisai Company Ltd. Tokyo , JP 112-8088 NYK-DO EE6-4053532-8/1/1 62JCY13 ENZYME INHIBITOR N.E.C.;INVESTIGATION DRUG;NEC 07-AUG-2008 DIRECTIONS Nipro Corporation Osaka , JP FLA-DO FR1-0012158-6/1/1 78F--KP DIALYSIS MACHINE EXPORT ONLY 11-AUG-2008 NOT LISTED Nipro Corporation Osaka , JP FLA-DO FR1-0012158-6/2/1 80F--RN INFUSION PUMP EXPORT ONLY 11-AUG-2008 NOT LISTED Nipro Corporation Osaka , JP FLA-DO FR1-0012231-1/1/1 78F--KP DIALYSIS MACHINE FOR EXPORT ONLY 11-AUG-2008 REGISTERED Ube Industries Ltd. Ube City, Yamaguchi , JP 1234 DET-DO 336-8835721-2/2/1 61LIS99 PRASUGREL DEGRADATION 11-AUG-2008 LACKS FIRM INCONSPICU Kikkoman Corporation Chiba Pref , JP 278-8601 LOS-DO 906-0823087-7/9/1 37JCP04 02213-KIKKOMAN SOMEN TSUYU,DIPPING SAUCE,DIM:2.83X7.75(INCH) 12-AUG-2008 NEEDS FCE NO PROCESS Nippon Del Monte Gunma Plant Gunma , JP LOS-DO 906-0823087-7/21/1 37JHT99 02185-KIKKOMAN TONKATSU SAUCE,BOTTLE 12-AUG-2008 NEEDS FCE NO PROCESS Chugai Pharmaceutical Corp Fukushima , JP SAN-DO 112-3878754-6/4/1 66VDY99 860766218280 SIGMART TABLETS 14-AUG-2008 NOT LISTED Japan Bioproducts Industry Co Ltd Tokyo , JP LOS-DO HD8-0090184-9/1/1 54ACH01 DIETARY SUPPLEMENT - 100% AMINO ACIDS (EXTRACTED FROM HUMAN 14-AUG-2008 POISONOUS UNAPPROVED Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/1 54YCL99 NANOJELLY 1 (Carrot & Vitamin) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/2 54YCL99 NANOJELLY 2 (Carrot & Collagen) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/3 54YCL99 NANOJELLY 3 (Carrot & Hyaluronic Acid) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/4 54YCL99 NANOJELLY 4 (Carrot & Pollen) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/5 54YCL99 NANOJELLY 5 (Carrot & Calcium) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/6 54YCL99 NANOJELLY 6 (Carrot & Royal Jelly) 19-AUG-2008 LIST INGRE LACKS N/C LACKS FIRM NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/7 54YCL99 NANOJELLY 7 (Carrot & Lutein) 19-AUG-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Genome Factory No.2 Furano-Shi , JP 076-0002 SAN-DO 427-7104152-4/1/8 54YCL99 NANOJELLY Hawaiian Rainbow Pack 19-AUG-2008 LIST INGRE LACKS N/C LACKS FIRM NUTRIT LBL NEEDS FCE NO PROCESS Ikari Sauce Co Ltd Osaka , JP 553 SAN-DO 597-0152650-7/21/3 37JCT99 ORIENTAL STYLE SAUCE 19-AUG-2008 LIST INGRE NEEDS FCE NO PROCESS Tawara Kanzume Co., Choshi Plant Choshi Chiba-Ken, JP LOS-DO 221-1892268-5/50/1 16EET05 SEASONED SCALLOP 21-AUG-2008 NEEDS FCE NO PROCESS Tawara Kanzume Co., Choshi Plant Choshi Chiba-Ken, JP LOS-DO 221-1892268-5/51/1 16EET02 SEASONED CLAM 21-AUG-2008 NEEDS FCE NO PROCESS Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/1/1 86H--JB BIOMETER 110V 25-AUG-2008 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/2/1 86H--JB HANDY PACHMETER FOR EXPORT ONLY 25-AUG-2008 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/3/1 86H--JB ULTRASONIC PACHYMETER 25-AUG-2008 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/4/1 86H--JB ULTRASONIC A/B SCANNER FOR EXPORT ONLY 25-AUG-2008 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/5/1 86H--JB AUTO LENSMETER 110V FOR EXPORT ONLY 25-AUG-2008 REGISTERED Tomey Corporation Nagoya -Shi , JP 4510051 FLA-DO 286-0667429-0/6/1 86H--JB TOPOGRAPHIC MODLING SYSTEM 25-AUG-2008 REGISTERED Atom Medical Corporation Tokyo , JP FLA-DO DM9-8010865-6/1/1 73C--AF ULTRASONIC NEBULIZER MODEL 303 W/ACCESSORIES 25-AUG-2008 REGISTERED NO 510(K) Nipro Corporation Osaka , JP FLA-DO FR1-0012358-2/1/1 73B--SP SPINAL NEEDLES FOR EXPORT ONLY 25-AUG-2008 REGISTERED NO 510(K) Nipro Corporation Osaka , JP FLA-DO FR1-0012358-2/2/1 78F--KP DIALYSIS MACHINES FOR EXPORT ONLY 25-AUG-2008 REGISTERED NO 510(K) Nipro Corporation Osaka , JP FLA-DO FR1-0012358-2/3/1 80F--RN INFUSION PUMP FOR EXPORT ONLY 25-AUG-2008 REGISTERED NO 510(K) Jilin Province Hongjiu Biotech Co., Ltd. Dalian , CN 116001 LOS-DO 510-7177515-2/1/1 54FBB12 PANAX GINGSENG EXTRACT POWDER 27-AUG-2008 PESTICIDES Matsushita Electric Industrial Co Ltd Osaka Osaka, JP 542 FLA-DO 406-0420398-0/6/1 95R--FW DVD PLAYER - FOR EXPORT ONLY 28-AUG-2008 NON STD Toshiba Medical Systems Co Ltd Bunkyo-Ku Tokyo, JP 113 FLA-DO DM9-8010911-8/1/1 76K--ZN ULTRASONIC SCANNING APPARATUS W/ACCS 28-AUG-2008 REGISTERED Kamuro Corporation Tokyo , JP DET-DO 112-4007654-0/1/1 86H--QZ 863386814042 TITANIUM SPEC FRAMES 29-AUG-2008 NOT LISTED REGISTERED Kamuro Corporation Tokyo , JP DET-DO 112-4007654-0/1/2 86H--QZ 863386814042 TITANIUM SPEC FRAMES 29-AUG-2008 NOT LISTED REGISTERED Kamuro Corporation Tokyo , JP DET-DO 112-4007654-0/2/1 86H--QZ 863386814042 PLASTIC SPEC FRAMES 29-AUG-2008 NOT LISTED REGISTERED Kawa Corporation Kobe , JP 650-0023 LOS-DO BUS-0003533-5/86/1 89L--YG WOOD FOOT MASSAGER 29-AUG-2008 NOT LISTED REGISTERED Kawa Corporation Kobe , JP 650-0023 LOS-DO BUS-0003533-5/88/1 89L--YG PLASTIC FOOT MASSAGER 29-AUG-2008 NOT LISTED REGISTERED