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
Egg Farms Co Ltd
Goryeong Gu , KR LOS-DO HE8-0096012-3/1/1
15AGN01 HARD BROILED CHICKEN EGGS-KWANDO EGGS BAKED IN LOESS(USDA #C
01-OCT-2008 FILTHY
Egg Farms Co Ltd
Goryeong Gu , KR LOS-DO HE8-0096012-3/1/2
15AGN01 HARD BROILED CHICKEN EGGS-KWANDO SMOKED EGGS(USDA #C-104274)
01-OCT-2008 FILTHY
Mammoth Confectionery Co
Kyeongki Seoul, KR SAN-DO D11-0116049-1/12/2
33EGT06 HARD CANDY (08692)
02-OCT-2008 UNSAFE COL
COLOR LBLG
Mammos Confectionery Co., Ltd.
Seongnam-si Gyeonggi-Do, KR 462807 NYK-DO U47-0462369-1/25/1
33EGT06 GREEN TEA FLAVOR CANDY
06-OCT-2008 UNSAFE COL
COLOR LBLG
Hansung Fishery Co., Ltd.
Pohang KR-47, KR 790-800 LOS-DO AQZ-0266668-6/5/1
16MGT03 CALAMARI SALTED W/RED PEPPER 150GR X 12
06-OCT-2008 LISTERIA
Ddukbaegi Food Company
Gyeongsangbugdo , KR SEA-DO N16-1038926-7/16/1
37KCT17 SOY BEAN PASTE
07-OCT-2008 LIST INGRE
FILTHY
FALSE
Okchun Agricultural Cooperative Food Processing
Choongbuk , KR 373-830 LOS-DO 805-0119155-7/5/1
29AHT99 KOREAN DRINK CARROT FLAVOR
08-OCT-2008 NEEDS FCE
NO PROCESS
Korea Optical
Daejon , KR FLA-DO JN8-0014966-6/1/1
86H--QG PLASTIC LENSES (500 PRS)
10-OCT-2008 REGISTERED
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/1
54FBT12 DRIED WHITE GINSENG / 4Y-CUR-1ST-50PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/2
54FBT12 DRIED WHITE GINSENG / 6Y-STR-1ST-15PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/3
54FBT12 DRIED WHITE GINSENG / 4Y-CUR-1ST-50PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/4
54FBT12 DRIED RED GINSENG / 6Y-HEAVEN-20PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/5
54FBT12 DRIED RED GINSENG / 6Y-HEAVEN-30PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/6
54FBT12 DRIED RED GINSENG / 6Y-HEAVEN-40PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/7
54FBT12 DRIED RED GINSENG / 6Y-EARTH-20PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/8
54FBT12 DRIED RED GINSENG / 6Y-EARTH-30PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/9
54FBT12 DRIED RED GINSENG / 6Y-EARTH-40PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/10
54FBT12 DRIED RED GINSENG / 6Y-GOOD-20PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/11
54FBT12 DRIED RED GINSENG / 6Y-GOOD-30PIECES
10-OCT-2008 PESTICIDES
DAEDONG KOREA GINSENG CO., LTD.
GEUMSAN-GUN KR-44, KR NONE LOS-DO HE8-0094872-2/1/12
54FBT12 DRIED RED GINSENG / 6Y-GOOD-40PIECES
10-OCT-2008 PESTICIDES
ochon
yeosu KR-46, KR 550220 SEA-DO N16-1038925-9/9/1
16MGH03 K61564- Dried Squid
14-OCT-2008 SALMONELLA
Myung Jin Eyewear Co
Taegu , KR 702051 SEA-DO 112-4490011-7/1/1
86H--QZ 865075060070/METAL OPTICAL FRAMES
15-OCT-2008 NOT LISTED
Boorim Agricultural Co.,Ltd.
Seoul , KR SAN-DO 597-0153318-0/6/1
25LGH26 DRIED SLICED RADISH
16-OCT-2008 SULFITELBL
Pyunghwa Industrial Co. - Hula Hoop Mfg.
Unknown , KR LOS-DO CAY-1006889-5/75/1B
89I--SA Magnetic (II) Health Hoop - Ilban (II)
17-OCT-2008 NOT LISTED
REGISTERED
Pyunghwa Industrial Co. - Hula Hoop Mfg.
Unknown , KR LOS-DO CAY-1006889-5/75/1C
89I--SA Jemimah Health Hoop (II) - Yuemima
17-OCT-2008 NOT LISTED
REGISTERED
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2017561-6/1/1
94V--01 27" CRT FLAT NON HI DEFINITION " EXPORTS ONLY, ISSUE DETENTI
20-OCT-2008 NON STD
ochon
yeosu KR-46, KR 550220 SEA-DO N16-1038925-9/6/1
16AGH56 K61164- Seasoned Dried Filefish (Big size)
21-OCT-2008 SALMONELLA
ochon
yeosu KR-46, KR 550220 SEA-DO N16-1038925-9/7/1
16AGH56 K61165- Seasoned Dried Filefish (Small size)
21-OCT-2008 SALMONELLA
ochon
yeosu KR-46, KR 550220 SEA-DO N16-1038925-9/8/1
16AGH56 K61166- Seasoned Dried Filefish (Shredded)
21-OCT-2008 SALMONELLA
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2017462-7/1/1
94V--07 FLAT 20" CRT TV NON HIGH DEFINITION / EXPORTS ONLY, ISSUE DE
22-OCT-2008 NON STD
J Optic Co Ltd
Seoul , KR DET-DO 112-4866912-2/1/1
86H--QG 865138724024 EYE GLASSES
24-OCT-2008 NOT LISTED
NON STD
Laseroptek Inc
Kyunggi , KR CHI-DO DQ7-0406490-5/1/1
79L--XU LASER SYSTEM - WOULD HEALING
27-OCT-2008 NOT LISTED
REGISTERED
NON STD
NO REGISTR
NO 510(K)
Hanall Pharmaceuti
Daejeon , KR SEA-DO 112-4914475-2/1/1
62ODZ14 862484954190 AMLODIPINE BESILATE
28-OCT-2008 UNAPPROVED
Mae Won Foods Co., Ltd.
Namwon City , KR LOS-DO HK1-0180864-8/2/2
30YEE99 PALDO CITRON WATER, FCE#13121,302X1511
28-OCT-2008 NO PROCESS
Samjin Globalnet Co., Ltd.
Seoul , KR 1234 LOS-DO WRE-5000431-6/3/1
16AGT56 SEASONED FILEFISH
29-OCT-2008 SALMONELLA
Maeil Dairy Industry Co.,Ltd.
Choongbook , KR NYK-DO 657-1013719-4/1/1
38AGN09 RICE PORRIDGE WITH SPINACH & TUNA
31-OCT-2008 NO PROCESS
Maeil Dairy Industry Co.,Ltd.
Choongbook , KR NYK-DO 657-1013719-4/1/3
38AGN99 SOUP WITH TUNA & TOFU
31-OCT-2008 NO PROCESS
Okchun Agricultural Cooperative Food Processing
Choongbuk , KR 373-830 LOS-DO M42-1224213-3/35/1
33LGT07 Raspberry Jelly Candy
31-OCT-2008 LIST INGRE
FALSE
Okchun Agricultural Cooperative Food Processing
Choongbuk , KR 373-830 LOS-DO M42-1224213-3/37/1
33LGT07 Ume Jelly candy
31-OCT-2008 UNSAFE COL
COLOR LBLG
YELLOW #5
Insung Pharmaceutical Co.,Ltd
Umsung-gun KR-43, KR 369-823 LOS-DO HD8-0090807-5/1/5
54YCA99 L-HANAMI B COM SUGAR COATED TABLET (DIETARY SUPPLEMENT)
31-OCT-2008 DIET INGRE
DIETARYLBL
USUAL NAME
Insung Pharmaceutical Co.,Ltd
Umsung-gun KR-43, KR 369-823 LOS-DO HD8-0090807-5/1/3
54YCA99 CHUNGYOONJIN KIYOMARU YEAST EXTRACT-SUGAR COATED TABLET(DIET
31-OCT-2008 DIET INGRE
DIETARYLBL
USUAL NAME
DO UM FOOD
KWANG JU KR-41, KR NONE LOS-DO CAY-1007162-6/27/1
24UGY99 KOREAN TRADITIONAL BUCKWHEAT TEA
31-OCT-2008 LIST INGRE
FALSE
LACKS FIRM
NUTRIT LBL
Dong A Confectionery Co.
Busan, Korea , KR LOS-DO CAY-1006889-5/66/1
33EGY06 SWEET FLAVORED JELLY (CRUDE) 380G
31-OCT-2008 LIST INGRE
LACKS FIRM
USUAL NAME
TRANSFAT
Caregen Co Ltd
Gyeongi-Do , KR LOS-DO AEK-9704027-9/1/1
53PD-99 COSMETICS
31-OCT-2008 CSTIC LBLG