Refusal Actions by FDA as Recorded in OASIS for Korea, Republic Of (South)

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Mammos Confectionary Corp Kyungi-Do , KR LOS-DO CAY-1003934-2/19/1 07YGY99 KOREAN CRACKER (SSAL DDUK)80G 02-JAN-2008 UNSAFE ADD Mammos Confectionary Corp Kyungi-Do , KR LOS-DO CAY-1003934-2/21/1 07YGY99 KOREAN CRACKER(MAKRONI)100G 02-JAN-2008 UNSAFE ADD Dae Pyung Co, Ltd. Kyung Sang Buk Do , KR LOS-DO 791-4697999-6/1/1 45TF-99 STEVIA 07-JAN-2008 UNSAFE ADD Daewoo Electronics Co Ltd Matogu Seoul, KR 686 FLA-DO EE6-2015908-1/1/1 94V--07 20" FLAT SCREEN NON HI DEFINITION / EXPORTS ONLY, PLS ISSUE 07-JAN-2008 NON STD B&Y TRADING CO., LTD. BUSAN KR-26, KR 611-820 LOS-DO CAY-1004033-2/2/1 29YGE99 AGED BLACK GARLIC PUCH DRINK 09-JAN-2008 NEEDS FCE NO PROCESS B&Y TRADING CO., LTD. BUSAN KR-26, KR 611-820 LOS-DO CAY-1004033-2/3/1 25LGE21 AGED BLACK GARLI 09-JAN-2008 NEEDS FCE NO PROCESS Seju Engineering Co., Ltd. Daejon City, Chuongnam , KR 1234 CHI-DO TZ8-3008167-3/1/1 75N--RH BREATALIZER 10-JAN-2008 REGISTERED Dong A Confectionery Co. Busan, Korea , KR LOS-DO CAY-1003434-3/14/1 33EGY06 FRUIT COCKTAIL (ASSORTED CANDY) 11-JAN-2008 UNSAFE COL NORTHEAST GLOBAL PUSAN KR-26, KR NONE LOS-DO CAY-1003434-3/37/1 54FEK12 KOREAN RED GINSENG AN ANTLER OF THE DEER 11-JAN-2008 NEEDS FCE NO PROCESS Dong A Confectionery Co. Busan, Korea , KR LOS-DO CAY-1003434-3/19/1 33EGY06 JEJU ORANGE 11-JAN-2008 INCONSPICU TRANSFAT NUTRIT LBL Jisang International Seoul , KR MIN-DO 144-9146663-9/1/1 86H--OI MAGNIFYING GLASSES:PLEASE DETAIN,FOR EVALUATION ONLY,WILL BE 15-JAN-2008 NOT LISTED Dong A Confectionery Co. Busan, Korea , KR SEA-DO N16-1035209-1/32/1 33EGT06 ASSORTED CANDY 16-JAN-2008 UNSAFE COL Daison Industries Co Ltd Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008899-8/67/1A 77J--YH Ear Pick 16-JAN-2008 NO ENGLISH REGISTERED Newtech Brush Co. Ltd. Deajeon City , KR MIN-DO FC7-0108213-1/1/1 76J--ES DENTAL FLOSS 18-JAN-2008 NOT LISTED REGISTERED Newtech Brush Co. Ltd. Deajeon City , KR MIN-DO FC7-0108213-1/1/2 76J--ES DENTAL FLOSS 18-JAN-2008 NOT LISTED Somo Optical Co Ltd Seoul , KR NOL-DO 112-0969705-4/1/1 86H--QG 713669786003/OPTICAL LENSE 23-JAN-2008 NOT IMPACT Yusung Mulsan Factory Goseong Goseong , KR SEA-DO 221-4019401-4/15/1 07YEE99 Silkworm Pupa 30-JAN-2008 FALSE NO PROCESS Young Woo Frozen Foods Co., Ltd Jeonrabuk Do , KR LOS-DO BVQ-0016837-6/1/1 24WGE99 ALOE DRINK 31-JAN-2008 NO PROCESS Han Zung Pharmaceutical Co.,Ltd. Taejon , KR LOS-DO BDN-0023432-3/2/1 54ECL99 HERBAL INFUSION(RED GINSENG, HOELEN, REHMANNIAE RADIX CRUDUS 31-JAN-2008 MFR INSAN LACKS FIRM LABELING HEALTH C