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
Poskom Co Ltd
Koyang, Gyunggi-Do , KR CHI-DO 677-0319978-5/1/1
90I--ZL VETERINARY PORTABLE UNIT (MODEL #POXIBLE) FOR RSNA 2007 EXHI
03-DEC-2007 NON STD
NO REGISTR
Poskom Co Ltd
Koyang, Gyunggi-Do , KR CHI-DO 677-0320049-2/1/1
90I--ZL VETERINARY PORTABLE UNIT (MODEL #PXM-160) FOR RSNA 2007 EXHI
03-DEC-2007 NON STD
NO REGISTR
Poskom Co Ltd
Koyang, Gyunggi-Do , KR CHI-DO 677-0320049-2/3/1
90I--ZL VETERINARY PORTABLE UNIT (MODEL #HTC-35B) FOR RSNA 2007 EXHI
03-DEC-2007 NON STD
NO REGISTR
Poskom Co Ltd
Koyang, Gyunggi-Do , KR CHI-DO 677-0320049-2/5/1
90I--ZL VETERINARY PORTABLE UNIT (MODEL #PDC-1000) FOR RSNA 2007 EXH
03-DEC-2007 NON STD
NO REGISTR
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/301/1
76E--FW TOUGUE CLEANER SET
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/340/1
76J--ES DENTAL FLOSS
05-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008774-3/537/1
76E--FW DENTAL BRUSH
05-DEC-2007 NOT LISTED
ORION CORP.
Busan KR-26, KR 602-030 LOS-DO CAY-1002665-3/4/1
33EGY06 SWEET FLAVORED JELLY (MA I GU MI) 48GX12P
10-DEC-2007 NUTRIT LBL
Seoul Frozen Foods
Goyang-Sikyonggido , KR 411440 SEA-DO N16-1033886-8/22/1
16WGT21 FROZEN SOUP - GOTGETANG
12-DEC-2007 FALSE
Seoul Frozen Foods
Goyang-Sikyonggido , KR 411440 SEA-DO N16-1033886-8/26/1
16WGT21 FROZEN SOUP - AL TANG
12-DEC-2007 FALSE
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008907-9/11/1
76J--ES DENTAL FLOSS
17-DEC-2007 NOT LISTED
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008907-9/202/1
76E--FW DENTAL BRUSH
17-DEC-2007 NOT LISTED
Mammos Confectionary Corp
Kyungi-Do , KR LOS-DO CAY-1002665-3/19/1
33EGY06 SWEET FLAVORED CANDY (JONG HAB) ASSORTED CANDY
17-DEC-2007 UNSAFE COL
Youngwoo Frozen Co Ltd
Jeonbuk , KR BLT-DO BMT-0016766-5/14/1
04CGI08 NOODLE W/SOUP BASE
18-DEC-2007 NO PROCESS
Korea C & B
Bucheon-Si, Gyeonggi-Do , KR LOS-DO ASW-1027254-9/8/1
66VBY99 CHEON SAENG HWA MEN SKIN (4 PIECE SET)
18-DEC-2007 NO ENGLISH
UNAPPROVED
Korea C & B
Bucheon-Si, Gyeonggi-Do , KR LOS-DO ASW-1027254-9/7/1
66VBY99 CHEON SAENG HWA SKIN (7 PIECE SET)
18-DEC-2007 NO ENGLISH
UNAPPROVED
Korea C & B
Bucheon-Si, Gyeonggi-Do , KR LOS-DO ASW-1027254-9/9/1B
53LD-03 OSHIAREE Q10 MEN LOTION ( 1 PIECE SET)
18-DEC-2007 CSTIC LBLG
Korea C & B
Bucheon-Si, Gyeonggi-Do , KR LOS-DO ASW-1027254-9/9/1A
66VBY99 OSHLAREE Q10 MEN SKIN (3 PIECE SET)
18-DEC-2007 UNAPPROVED
Woojin T.N.D Co.
Seoul , KR LOS-DO DQ7-0172076-4/6/1
73B--WI NEEDLE, ACUPUNCTURE
18-DEC-2007 NO ENGLISH
Woojin T.N.D Co.
Seoul , KR LOS-DO DQ7-0172076-4/9/1
66VBY99 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION;
18-DEC-2007 UNAPPROVED
Lotte Confectionery Co., Ltd.
Seoul , KR 150-964 SAN-DO JG6-1129689-2/7/1
33EGT06 HARD CANDY
19-DEC-2007 UNSAFE COL
Nam Do
Jeonranamdo , KR LOS-DO AQZ-0254431-3/7/1
16AGH01 DRIED ANCHOVY (150 CTNS)
31-DEC-2007 BACTERIA
INSANITARY
DOOSUNG FOOD
SEOUL KR-11, KR 158-050 LOS-DO HE8-0087544-6/9/1
54FYT12 Siberian Giseng
31-DEC-2007 SBGINSENG