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
Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0008965-7/17/1B 53ID-02 MOUTHWASH 03-MAR-2008 CSTIC LBLG Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0008993-9/20/1 53ID-02 MOUTH WASH 03-MAR-2008 CSTIC LBLG Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0008993-9/163/1B 80F--OR MEDICAL COTTON SWABS LINE 178 03-MAR-2008 NOT LISTED Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009117-4/15/1B 89I--TW Supporter, finger, wrist, ankle 03-MAR-2008 NOT LISTED DIRECTIONS NO ENGLISH Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO ANP-0009217-2/176/1 77J--YH EAR PICK 03-MAR-2008 NOT LISTED Ajou Medics Co. Ltd. Seoul , KR LOS-DO WIB-1210676-4/2/1 66VBY99 DR.ESLEE HYGLENIC INNER CLEANSER 150ML 06-MAR-2008 NOT LISTED Orionpop Co Ltd Kyung-Buk , KR FLA-DO M21-0737267-6/1/1 95R--HF PLASMA MONITORS (FOR EXPORT ONLY, PLEASE REFUSE) 10-MAR-2008 NO REGISTR Daewoo Electronics Co Ltd Matogu Seoul, KR 686 FLA-DO EE6-2016208-5/1/1 95L--22 NON HI DEFINITION, NON FLAT 19" CRT / FOR EXPORTS ONLY 10-MAR-2008 NON STD Gon Gan Industry Co Kyunggi Do , KR NYK-DO BWR-0016145-1/1/1 16EGD03 FROZEN OYSTER 10-MAR-2008 POISONOUS Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1003434-3/42/1 16YGH09 SALTED ANCHOVY SAUCE (MYUL-CHI-ACT-JUJ) 1KG 12-MAR-2008 NO ENGLISH Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1003434-3/43/1 16YGH09 SALTED ANCHOVY SAUCE 500G 12-MAR-2008 NO ENGLISH Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1003434-3/44/1 16YGH09 SALTED FISH SAUCE (KKANARI) 1KG 12-MAR-2008 INCONSPICU NUTRIT LBL Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1003434-3/45/1 16YGI09 SALTED FISH SAUCE (KKANARI) 2.5KG 12-MAR-2008 LIST INGRE LACKS FIRM TRANSFAT Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1003434-3/46/1 16YGH09 SALTED FISH SAUCE (KKANARI) 500G 12-MAR-2008 LIST INGRE LACKS FIRM NO ENGLISH TRANSFAT NUTRIT LBL Joeun Food Co., Ltd Kyungnam , KR LOS-DO CAY-1003434-3/52/1 33EGY06 MANGO (FLAVOR CANDY) 12-MAR-2008 LIST INGRE LACKS FIRM TRANSFAT Charmcare Co. Ltd Seoul , KR 153023 SEA-DO 112-1683254-6/1/1 73D--QA 8597-1745-0585 Pulse Oximeters - w/o veterinary-use-only lab 13-MAR-2008 NOT LISTED NO 510(K) Daewoo Electronics Co Ltd Matogu Seoul, KR 686 FLA-DO EE6-2016206-9/1/1 94V--07 29" FLAT TV / FOR EXPORT ONLY, PLEASE ISSUE DETENTION NOTICE 14-MAR-2008 NO REGISTR Daewoo Electronics Co Ltd Matogu Seoul, KR 686 FLA-DO EE6-2016203-6/1/1 95L--22 NON HI DEFINITION, NON FLAT 19" CRT / FOR EXPORTS ONLY 14-MAR-2008 NO REGISTR Korea Red Ginseng Kongsa Co., Ltd. Chonan , KR 330-910 LOS-DO BVE-5010873-9/1/1 54YBK04 RED GINSENG LIQUID 17-MAR-2008 NEEDS FCE NO PROCESS Korea Red Ginseng Kongsa Co., Ltd. Chonan , KR 330-910 LOS-DO BVE-5010874-7/1/1 54YBK04 RED GINSENG LIQUID 17-MAR-2008 NEEDS FCE NO PROCESS Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SAN-DO ANP-0009200-8/32/1 66PAJ99 SUNBLOCK FOR KIDS 18-MAR-2008 NOT LISTED NO ENGLISH Lotte Confectionery Co., Ltd. Seoul , KR 150-964 SEA-DO 551-6633179-8/2/2 33EET06 SUGAR CANDY 18-MAR-2008 UNSAFE COL cheongwoo confectionery co., ltd. seoul KR-11, KR 136-111 LOS-DO CAY-1004107-4/3/1 33EGY06 SWEET FLAVORED CANDY (JONG HAP) 120G 18-MAR-2008 LACKS FIRM TRANSFAT LABELING INTRADE CORPORATION SEOUL KR-11, KR 138-160 LOS-DO CAY-1004107-4/4/1 29AGY99 SWEET SOFT DRINK (GREEN TEA, PET) 500ML 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS HASUNJUNG GENERAL FOOD CO., LTD ANSUNG KR-41, KR 456-843 LOS-DO CAY-1004107-4/9/1 16YGH09 SALTED ANCHOVY SAUCE (MYUL-CHI-ACT-JUJ) 500G 18-MAR-2008 LIST INGRE LACKS FIRM NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS HASUNJUNG GENERAL FOOD CO., LTD ANSUNG KR-41, KR 456-843 LOS-DO CAY-1004107-4/10/1 16YGH09 SALTED ANCHOVY SAUCE (MYUL-CHI-ACT-JUJ) 1KG 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1004107-4/11/1 25JGY26 PICKLED RADISH BY VINEGAR (IJEOL) 400G 18-MAR-2008 LIST INGRE LACKS FIRM LABELING Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1004107-4/12/1 25JGY26 PICKLED RADISH BY VINEGAR (CHIJAIJEOL) 400G 18-MAR-2008 LIST INGRE LACKS FIRM LABELING Hasunjung General Good Co., Ltd. Gyeonggi-Do, Korea , KR LOS-DO CAY-1004107-4/13/1 25JGY26 PICKLED RADISH BY VINEGAR (KIMBAB) 400G 18-MAR-2008 LIST INGRE LACKS FIRM LABELING PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/20/1 29AGY99 SWEET SOFT DRINK (RED GINSENG) 100MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/21/1 29AGY99 SWEET SOFT DRINK (BLACK GARLIC) 120MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/22/1 29AGY99 SWEET SOFT DRINK (BERRIES) 100MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/23/1 29AGY99 SWEET SOFT DRINK (VITAMINE) 100MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/24/1 29AGY99 SWEET SOFT DRINK (MUSHROOM) 110MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS PUREPLUS CO., LTD(SANG-A) Hamyang KR-48, KR 676813 LOS-DO CAY-1004107-4/25/1 29AGY99 SWEET SOFT DRINK (POMEGRANATE) 100MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS LEE'S CO.,LTD. Busan KR-26, KR 607-110 LOS-DO CAY-1004107-4/45/1 29AGY99 SWEET SOFT DRINK 75MLX10P 18-MAR-2008 LIST INGRE LACKS FIRM LACKS N/C NO ENGLISH TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS Koryo Insam Mfg Co Ltd Kyunggi Do , KR LOS-DO FD2-0188177-4/1/9 54EGK12 KOREAN GINSENG TEA 30GX3/BOX 19-MAR-2008 NO PROCESS Koryo Insam Mfg Co Ltd Kyunggi Do , KR LOS-DO FD2-0188177-4/1/10 54EGK12 KOREAN GINSENG TEA 20GX10(RED)/BOX 19-MAR-2008 NO PROCESS Dong-A Pharmaceutical Co., Ltd. Seoul , KR LOS-DO WRE-0355960-6/1/1 29ACT99 Energy Drink (non-carbonated) 19-MAR-2008 NEEDS FCE NO PROCESS Hansung Fishery Co., Ltd. Pohang KR-47, KR 790-800 LOS-DO AQZ-0254431-3/6/1 16MGT03 FROZEN SEASONED CUTTLEFISH 19-MAR-2008 LISTERIA Enprani Co. Seoul , KR LOS-DO DQ7-0172131-7/1/4 66PPY99 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION; 19-MAR-2008 NOT LISTED Enprani Co. Seoul , KR LOS-DO DQ7-0172131-7/1/17 66PPY99 FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES);POWDER; 19-MAR-2008 NOT LISTED Enprani Co. Seoul , KR LOS-DO DQ7-0172131-7/1/18 66PPY99 FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES);POWDER; 19-MAR-2008 NOT LISTED Enprani Co. Seoul , KR LOS-DO DQ7-0172131-7/1/19 66PPY99 FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES);POWDER; 19-MAR-2008 NOT LISTED Medicor Co Ltd Seoul , KR SEA-DO 112-1612226-0/1/1 74J--OM 8410-9969-8941 PULSE ANALYZERS 25-MAR-2008 NOT LISTED REGISTERED Global Top Inc Gyeonggido , KR SEA-DO 112-1675296-7/1/1 76E--IH 957362434775 TOPCERAM 25-MAR-2008 NO 510(K) K J I Industrial Co., Ltd. Busan , KR 702 800 SEA-DO 112-1685745-1/1/1 80F--QM 9483-5037-4572 Ionic Detox Foot Patches x 5000 bags of 25 "b 25-MAR-2008 DIRECTIONS UNAPPROVED Hanbul Cosmetics Co. Seoul , KR LOS-DO WIB-1212918-8/32/1 53CC-04 LUICHEL E GOLDEN RICH EYE BALM 27-MAR-2008 UNAPPROVED Hanbul Cosmetics Co. Seoul , KR LOS-DO WIB-1212918-8/33/1 53LD-06 LUICHEL W NUTRY EMULSION 27-MAR-2008 UNAPPROVED Hanbul Cosmetics Co. Seoul , KR LOS-DO WIB-1212918-8/34/1 53GC-06 LUICHEL SHINY W BASE 27-MAR-2008 UNAPPROVED Hanbul Cosmetics Co. Seoul , KR LOS-DO WIB-1212918-8/35/1 53LD-06 LUICHEL W SILKY SERUM 27-MAR-2008 UNAPPROVED