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
Van Min H Hong
Chau , VN CIN-DO AEK-9424942-8/1/2
60WDH39 LIVER MEDICATIONS FOR PERSONAL USE - THYMOLAN
02-APR-2008 UNAPPROVED
Van Min H Hong
Chau , VN CIN-DO AEK-9424942-8/1/3
64LDH50 LIVER MEDICATIONS FOR PERSONAL USE - GRANIS
02-APR-2008 UNAPPROVED
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/1/1
29AGY99 WILD GINSENG DRINK (70ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/2/1
29AGY99 WILD GINSENG DRINK (70ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/3/1
29AGY99 WILD GINSENG DRINK (70ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/4/1
29AGY99 CODONOPSIS LACEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/5/1
29AGY99 CODONOPSIS LANCEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/6/1
29AGY99 CODONOPSIS LACEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/7/1
29AGY99 CODONOPSIS LANCEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/8/1
29AGY99 CODONOPSIS LACEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/9/1
29AGY99 CODONOPSIS LANCEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/10/1
29AGY99 CODONOPSIS LACEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/11/1
29AGY99 CODONOPSIS LACEOLATA DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/12/1
29AGY99 ACANTHOPANAX DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/13/1
29AGY99 ACANTHOPANAX DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Chunji Farmers Association
Andong KR-47, KR 760845 LOS-DO CAY-1005487-9/14/1
29AGY99 ACANTHOPANAX DRINK (100ML)
02-APR-2008 NEEDS FCE
NO PROCESS
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO AEK-9436818-6/1/3
53MC-99 ANTI AGING COSMETICS
03-APR-2008 NOT LISTED
Daegok Agricultural Cooperative
Jinju-si, Kyongsangnam-Do Kr-48, KR 660-913 SEA-DO MA7-0304616-3/1/1
20AFB14 FRESH STRAWBERRIES
03-APR-2008 PESTICIDE
K-One Optical Co Ltd
Gwanju , KR LOS-DO BRN-0101030-9/1/1
86H--QG LENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION);;
03-APR-2008 NOT LISTED
REGISTERED
Life Industry Co.Ltd
Hadong , KR LOS-DO FD2-0186270-9/1/1
29ACE99 PINE NEEDLE DRINK(100GX60EA)1836BOX
07-APR-2008 LACKS N/C
NO ENGLISH
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
DAEHYUN SHINNONG INC.
Jincheon-gun KR-43, KR 365-843 LOS-DO FD2-0188096-6/38/1
54ECT99 ASIASARUM ROOT
08-APR-2008 UNSFDIETLB
DAEHYUN SHINNONG INC.
Jincheon-gun KR-43, KR 365-843 LOS-DO FD2-0188096-6/47/1
66YJY99 BORNEOLUM
08-APR-2008 POISONOUS
Bing Grae Company Ltd. (Office & Plant)
Namyangju , KR 472100 SAN-DO D52-0927569-7/11/6
03FGT02 KOREAN CRACKER IN PL. BAG, HOT FLAVOR
08-APR-2008 UNSAFE COL
COLOR LBLG
Bing Grae Company Ltd. (Office & Plant)
Namyangju , KR 472100 SAN-DO D52-0927569-7/11/5
03FGT02 KOREAN CRACKER IN PL. BAG, CRAB FLAVOR
08-APR-2008 UNSAFE COL
COLOR LBLG
Bing Grae Company Ltd. (Office & Plant)
Namyangju , KR 472100 SAN-DO D52-0927569-7/11/2
03FGT02 KOREAN CREACKER IN PL. BAG
08-APR-2008 UNSAFE COL
COLOR LBLG
Bachar Aljammal
Damacus , SY NYK-DO AEK-9098195-8/1/1
64MCP04 HUMAN CHRIONIC GONADOTROPIN
08-APR-2008 UNAPPROVED
Chong Kun Dang Healthcare FD Co.,Ltd
Chungju KR-43, KR 380-250 LOS-DO BAH-0512895-2/2/1
54GCT99 SOFT SHELLED TURTLE POWDER
09-APR-2008 UNSFDIETUS
Mammos Confectionary Corp
Kyungi-Do , KR CHI-DO AD3-0314775-6/9/1
03HGT99 BROWN RICE CRACKER
10-APR-2008 UNSAFE COL
Seju Engineering Co., Ltd.
Daejon City, Chuongnam , KR 1234 CHI-DO BTF-0011225-6/1/1
91D--JZ PERSONAL PORTABLE BREATHALYZERS
11-APR-2008 REGISTERED
NO 510(K)
Lg Electronics
Seoul , KR 150 LOS-DO 231-2199132-9/1/1
96M--01 CONVECTION OVEN
11-APR-2008 NO REGISTR
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009214-9/4/1
80K--GX EYE TREATMENT
14-APR-2008 NOT LISTED
DIRECTIONS
NO 510(K)
K J I Industrial Co., Ltd.
Busan , KR 702 800 LOS-DO 332-0186697-8/1/1
80F--QM Ionic Detox Foot Patch
19-APR-2008 FALSE
REGISTERED
NO 510(K)
Hanchang Corporation
Seoul , KR LOS-DO 442-0118679-6/2/1
63RBY06 FLOURIDE TOOTHPASTE REGULAR
19-APR-2008 NOT LISTED
UNAPPROVED
Hanchang Corporation
Seoul , KR LOS-DO 442-0118679-6/2/2
63RBY06 FLOURIDE TOOTHPASTE MINT
19-APR-2008 NOT LISTED
UNAPPROVED
Natuzen Co.,Ltd
451-7 Npnhyun-Dong,Inch , KR SEA-DO 112-2158442-1/1/1
66YBY99 862482284271/MAN SUN CREAM 50G
21-APR-2008 NO ENGLISH
UNAPPROVED
Dives Cosmetics Corp
Kyunggi , KR SEA-DO 112-2158442-1/1/2
66YAY99 862482284271/ NATURAL WHITE CREAM 200G
21-APR-2008 NO ENGLISH
UNAPPROVED
Dives Cosmetics Corp
Kyunggi , KR SEA-DO 112-2158442-1/1/3
66YBY99 862482284271/WRINKLE CARE CREAM 30G
21-APR-2008 NO ENGLISH
UNAPPROVED
Samjin Globalnet Co., Ltd.
Busan , KR 1234 ATL-DO 100-7000165-5/54/1
16AGD56 FILE FISH PRESSED JOMIGEEPO GOLD SGTEPHANOLEPIS CIRRHIFER
21-APR-2008 SALMONELLA
Lotte Confectionery Co., Ltd.
Seoul , KR 150-964 CHI-DO AD3-0315169-1/1/1
33EGT99 Herb Candy
22-APR-2008 UNSAFE COL
COLOR LBLG
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009485-5/18/1
53ID-02 MOUTH MASH
22-APR-2008 CSTIC LBLG
Dasung Ins Corp.
Gyunggido , KR LOS-DO DE0-0084046-7/1/1
54YYK04 GINSENG EXTRACT
22-APR-2008 LIST INGRE
LACKS FIRM
LACKS N/C
NO ENGLISH
USUAL NAME
NUTRIT LBL
NEEDS FCE
NO PROCESS
Okchun Agricultural Cooperative Food Processing
Choongbuk , KR 373-830 LOS-DO 805-0118030-3/8/1
29AET99 SOFT DRINK PLUM FLAVOR
23-APR-2008 LIST INGRE
LACKS FIRM
LACKS N/C
NO ENGLISH
NEEDS FCE
Okchun Agricultural Cooperative Food Processing
Choongbuk , KR 373-830 LOS-DO 805-0118030-3/11/1
20DEP09 GRAPE FLAVOR SOFT DRINK
23-APR-2008 NEEDS ACID
NO PROCESS
Changhee Confectionery Co., Ltd.
Namyangju City KR-41, KR 472-851 LOS-DO 805-0118030-3/27/1
03HGT07 COOKIES
23-APR-2008 COLOR LBLG
YELLOW #5
Orion Confectionery Co., Ltd.
Seoul , KR 140-725 LOS-DO 805-0118030-3/22/1
33LGT07 KOREAN JELLY BEAN
23-APR-2008 LIST INGRE
LACKS FIRM
LACKS N/C
NO ENGLISH
Jieun Plus Co., Ltd.
Geumjeong-gu KR-26, KR 609-800 LOS-DO CAY-1005266-7/1/1B
16AGY01 Salted Large-Eyed Herrings
25-APR-2008 LIST INGRE
LACKS FIRM
NEEDS ACID
Jieun Plus Co., Ltd.
Geumjeong-gu KR-26, KR 609-800 LOS-DO CAY-1005266-7/1/1F
16AGY01 Salted Shellfish
25-APR-2008 LIST INGRE
LACKS FIRM
NEEDS FCE
NO PROCESS
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/1
16MGN03 SPICY ROASTED SQUID BULK
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/2
16MGN03 SPICY ROASTED SQUID BULK
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/3
16MGN03 SPICY ROASTED SQUID BULK
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/4
16MGN03 ROASTED BUTTER SQUID BULK
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/5
16MGN03 SOFT ROASTED SQUID BULK
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/6
16MGN03 SMOKED SQUID LEG
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/7
16MGN03 SPICY ROASTED SQUID
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/8
16MGN03 ELECTRICALLY ROASTED SQUID
28-APR-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 LOS-DO HE8-0090677-9/1/9
16MGN03 SOFT ROASTED SQUID
28-APR-2008 MFRHACCP
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2016496-6/1/1
94V--05 20" FLAT CRT NON HI DEFINITION - EXPORTS ONLY- PLS ISSUE DET
29-APR-2008 NON STD
Daewoo Electronics Co Ltd
Matogu Seoul, KR 686 FLA-DO EE6-2016497-4/1/1
94V--07 20" FLAT SCREEN NON HI DEFINITION / EXPORTS ONLY, PLS ISSUE
29-APR-2008 NON STD
Crown Confectionery Co., LTD.
Kyung Ki-Do , KR CHI-DO 120-0215248-1/12/3
03NGT01 CAKE-FILLED LONX
29-APR-2008 LIST INGRE
LACKS FIRM
USUAL NAME
ALLERGEN
TRANSFAT
NUTRIT LBL
Natuzen Co
Incheon , KR SEA-DO 112-2349873-7/1/1
53LY-01 8624-8228-4293 NWC21 Collagen Cellulose Mask, 500 pcs
30-APR-2008 CSTIC LBLG
Cleans Cosmetics
Gwang Myung , KR SEA-DO 112-2349873-7/1/2
66VBY99 8624-8228-4293 NWC21 Whitening, Wrinkle-Care & SPF35 UV Bloc
30-APR-2008 UNAPPROVED