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
Lotte Confectionery Co., Ltd.
Seoul , KR 150-964 CHI-DO AD3-0311891-4/9/1
33EGT99 CANDY
06-NOV-2007 UNSAFE COL
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008552-3/254/1
76E--FW TOOTHBRUSH
07-NOV-2007 REGISTERED
Samsung Herb Medic
Gangwon-Do , KR SEA-DO 112-8700874-4/1/1
54FCT99 629579885129 GASTRODIA ELATA SUPPLEMENT
08-NOV-2007 FALSE
LABELING
NUTRIT LBL
Inwang Corp.
Seoul , KR NYK-DO 657-1010259-4/42/1
76E--FW TOOTHBRUSH SET
13-NOV-2007 NOT LISTED
REGISTERED
Inwang Corp.
Seoul , KR NYK-DO 657-1010259-4/42/2
76E--FW TOOTHBRUSH SET
13-NOV-2007 NOT LISTED
REGISTERED
Inwang Corp.
Seoul , KR NYK-DO 657-1010259-4/42/3
76E--FW TOOTHBRUSH SET
13-NOV-2007 NOT LISTED
REGISTERED
HAECHAWON
HADONG KR-48, KR 766813 LOS-DO WRE-0353856-8/4/1
24AGP16 PICKLED BLACK BEANS
13-NOV-2007 NO PROCESS
WOORINE FOOD
HADONG KR-48, KR 667842 LOS-DO WRE-0353856-8/6/1
37JHT05 SOY SAUCE
13-NOV-2007 NO PROCESS
CHEONGHAKDONG SAMSUNDANG CO.,LTD.
HADONG KR-48, KR 667-883 LOS-DO WRE-0353856-8/7/1
37JHT05 SOY SAUCE
13-NOV-2007 NO PROCESS
SEONIL INT CO., LTD.
INCHEON KR-28, KR 401-722 LOS-DO BWR-0012009-3/4/1A
29YHE99 MUSHROOM FLAVOUR WATER (SANG WHANG)
13-NOV-2007 NEEDS FCE
NO PROCESS
SEONIL INT CO., LTD.
INCHEON KR-28, KR 401-722 LOS-DO BWR-0012009-3/4/1B
29YHE99 HOVENIA DULCIS WATER
13-NOV-2007 NEEDS FCE
NO PROCESS
Choongwae Humantech Corporation
Seoul , KR LOS-DO W92-0139902-4/4/1
89L--YG VOKS PRESSURE (MASSAGE APPARATUS)
15-NOV-2007 REGISTERED
Choongwae Humantech Corporation
Seoul , KR LOS-DO W92-0139902-4/4/2
89L--YG CHEOMI THEMOMETER (MASSAGE APPARATUS)
15-NOV-2007 REGISTERED
Sungwon Pharmaceutical Ltd.
Kyunggi-Do , KR LOS-DO WRE-0352382-6/5/1
66V--99 Nano Silver Toothpaste
15-NOV-2007 NOT LISTED
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO WRE-0353975-6/5/1
54ACB99 Dongsung Lecithin
15-NOV-2007 NO ENGLISH
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO WRE-0353975-6/5/2
54ACB99 CHLORELLA(FOOD SUPPLEMENTAL)
15-NOV-2007 NO ENGLISH
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO WRE-0353975-6/6/1
53IG-01 NANO TOOTHPASTE
15-NOV-2007 UNAPPROVED
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO WRE-0353975-6/6/2
53IG-01 INDAN TOOTHPASTE
15-NOV-2007 UNAPPROVED
Yusung Mulsan Factory
Goseong Goseong , KR LOS-DO 805-0117500-6/2/1
70YY-99 "BOILED SILK WORM, FOR BIRD FEED"
15-NOV-2007 UNSAFE ADD
USUAL NAME
NEEDS FCE
NO PROCESS
Lotte Confectionery Co., Ltd.
Seoul , KR 150-964 LOS-DO CAY-1002665-3/12/1
33EGY06 SWEET FLAVORED CANDY (VITA) 20GX8P
15-NOV-2007 NUTRIT LBL
Crown Confectionery Co., Ltd.
Seoul , KR LOS-DO CAY-1002665-3/37/1
33EGY06 SWEET FLAVORED JELLY (GRAPE FLAVORED) 30GX15
15-NOV-2007 UNSAFE COL
Crown Confectionery Co., Ltd.
Seoul , KR LOS-DO CAY-1002665-3/38/1
33EGY06 SWEET FLAVORED JELLY (STRAWBERRY FLAVORED) 30GX15
15-NOV-2007 UNSAFE COL
Crown Confectionery Co., Ltd.
Seoul , KR LOS-DO CAY-1002665-3/39/1
33EGY06 SWEET FLAVORED JELLY (COLA FLAVORED) 30GX15
15-NOV-2007 UNSAFE COL
Mammos Confectionary Corp
Kyungi-Do , KR LOS-DO CAY-1002665-3/18/1
33EGY06 SWEET FLAVORED CANDY (GE PI) CINNAMON CANDY
16-NOV-2007 LIST INGRE
LACKS N/C
TRANSFAT
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2015638-4/1/1
94V--05 20" FLAT NON HIGH CRT TV " FOR EXPORTS ONLY, PLS ISSUE DETEN
19-NOV-2007 NO REGISTR
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2015550-1/1/1
94V--07 20" FLAT SCREEN NON HI DEFINITION / EXPORTS ONLY, PLS ISSUE
19-NOV-2007 NO REGISTR
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2015575-8/1/1
94V--05 20" FLAT CRT NON HI DEFINITION " EXPORT ONLY, PLS ISSUE DETE
19-NOV-2007 NON STD
Hyosun Nongsan
Kyungbuk , KR SAN-DO AY0-0048510-4/1/1
66VBL99 MIXTURES VEGETABLE JUICE FOR DRINK
20-NOV-2007 UNAPPROVED
Cheong Jung Na Ru Food
Ochang-Myeon, Chungbuk , KR LOS-DO M42-1211824-2/9/1
16XGT30 FROZEN SALTED CLAMS
20-NOV-2007 NUTRIT LBL
Cheong Jung Na Ru Food
Ochang-Myeon, Chungbuk , KR LOS-DO M42-1211824-2/10/1
16XGT32 FROZEN SALTED SEASONED OYSTERS
20-NOV-2007 NUTRIT LBL
Dong Nam Industries Co Ltd
Hwasung City , KR LOS-DO AYU-1013307-0/10/1
89I--LY INFRARED LAMP
27-NOV-2007 NOT LISTED
REGISTERED
Young Shin Food Co. Ltd.
Seoul , KR 1234 LOS-DO WRE-0355068-8/14/1
16AGH01 DRIED ANCHOVIES
28-NOV-2007 MFR INSAN