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
Il Hwa Co Ltd
Choong Buk , KR SAN-DO D11-0115174-8/3/2
24WHE99 ALOE JUICE (FCE 12580) (SID 020806004)
07-JUL-2008 NO PROCESS
Crown Confecionery
Jinchun Kun , KR CHI-DO 120-0215248-1/13/1
33LGT06 CANDY-MY CHEW-STRAWBERRY FLAVORED
08-JUL-2008 UNSAFE COL
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/1/1
53LC-01 BODY SET
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/2/1
53LC-01 PEELING GEL
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/3/1
53LC-01 HAEYOONDAN CREAM
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/4/1
53GY-99 SKIN COVER
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/5/1
53JY-01 CLEANSING FOAM
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/6/1
53LC-99 MASSAGE CREAM
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/7/1
53LC-01 3 PC SET
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/8/1
53LC-01 2 PC SET
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/9/1
53LC-01 ESSENCE
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/10/1
53LC-01 AMPLE ESSENCE
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/11/1
53LC-01 FOR MEN 2 PC SET
09-JUL-2008 CSTIC LBLG
Rosee Cosmetic
Seoul , KR NYK-DO 657-1012455-6/12/1
53LC-01 PEELING GEL
09-JUL-2008 CSTIC LBLG
Kyung Book Apple Growers
Kyung Book , KR LOS-DO M42-1221485-0/1/1
29AHE05 KOREAN DRINK (PLUM FLAVOR)
09-JUL-2008 NEEDS FCE
NO PROCESS
Kyung Book Apple Growers
Kyung Book , KR LOS-DO M42-1221485-0/2/1
29AHE05 KOREAN DRINK (PEAR FLAVOR)
09-JUL-2008 NEEDS FCE
NO PROCESS
Kyung Book Apple Growers
Kyung Book , KR LOS-DO M42-1221485-0/3/1
29AHE02 KOREAN DRINK (MANDARIN ORANGE FLAVOR)
09-JUL-2008 NEEDS FCE
NO PROCESS
Kyung Book Apple Growers
Kyung Book , KR LOS-DO M42-1221485-0/4/1
29AHE02 KOREAN DRINK (MANDARIN FLAVOR)
09-JUL-2008 NEEDS FCE
NO PROCESS
Kyung Book Apple Growers
Kyung Book , KR LOS-DO M42-1221485-0/5/1
29AHE02 KOREAN DRINK (MANDARIN ORANGE FLAVOR)
09-JUL-2008 NEEDS FCE
NO PROCESS
Bada Fishery Co.
Yangyang-Gun KR-42, KR 215-851 LOS-DO 082-0302427-1/1/1
16JGN01 FRZ COOKED SNOW CRAB MEAT, VACUUM PACKED
09-JUL-2008 LISTERIA
Inel Cosmetics Co.
Seoul , KR LOS-DO E8L-1003905-0/9/1
53MD-99 NEW IPKN WSUCCESS S-BLOCK
11-JUL-2008 NOT LISTED
CSTIC LBLG
Livechem Inc
Jeju City , KR LOS-DO AEK-9686586-6/1/1
66YBO99 MUSCLE OINTMENT (MITONOL)
14-JUL-2008 NOT LISTED
UNAPPROVED
SEO KANG TRADING CO.,LTD
SEOUL KR-11, KR 130-864 LOS-DO CAY-1007195-6/23/1
54FYY55 EPHEDRA HERB
14-JUL-2008 EPHEDALK
Il Hwa Co Ltd
Choong Buk , KR SAN-DO D11-0115481-7/2/2
24WHE99 ALOE JUICE (13832) (FCE 12580) (SID 020806004)
14-JUL-2008 NO PROCESS
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 NYK-DO 657-1013146-0/6/1
16MGN03 SOFT ROASTED SQUID
15-JUL-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 NYK-DO 657-1013146-0/6/2
16MGN03 SPICY ROASTED SQUID
15-JUL-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 NYK-DO 657-1013146-0/6/3
16MGN03 SOFT ROASTED SQUID
15-JUL-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 NYK-DO 657-1013146-0/6/4
16MGN03 ROASTED BUTTER SQUID
15-JUL-2008 MFRHACCP
Jeong Hwa Foods Co., Ltd.
Pohang Kyungbuk-Do, KR 42314 NYK-DO 657-1013146-0/6/5
16MGN03 SMOKED SQUID LEG
15-JUL-2008 MFRHACCP
MILAL FOOD CO., LTD.
gwangju KR-29, KR 506814 SWI-DO WRE-0360922-9/4/1
24UGH99 DRIED RADISH LEAVES
15-JUL-2008 FILTHY
Dy Food Inc.
Gyeongsangbug-Do , KR LOS-DO CAY-1006964-6/1/1
29ACE99 ALOE DRINK
16-JUL-2008 NEEDS FCE
NO PROCESS
Jayeonwon Food Inc.
Seoul KR-11, KR 134-072 LOS-DO CAY-1006006-6/4/1
07YGY99 SNACK (WORLDCUP OPO) 40G
18-JUL-2008 LIST INGRE
STD IDENT
TRANSFAT
NUTRIT LBL
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO AEK-9515800-8/1/1
53LD-10 SMOOTHING CREAM
21-JUL-2008 CSTIC LBLG
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO AEK-9499069-0/1/1
66VDJ99 ANTI AGING CREAM
21-JUL-2008 DIRECTIONS
UNAPPROVED
JEONG WON IND.CO.
BOSUNG Jeollanam-Do, KR 546-800 SEA-DO U47-0460549-0/79/1
02DFT06 SPROUTED BLACK RICE
21-JUL-2008 INCONSPICU
PESTICIDES
LABELING
BAKELINE CO.LTD
SASANG-GU KR-26, KR 617-825 SEA-DO U47-0460987-2/4/1
23FEN04 CHESTNUT (SLICED)
21-JUL-2008 UNSAFE COL
NEEDS FCE
BAKELINE CO.LTD
SASANG-GU KR-26, KR 617-825 SEA-DO U47-0460987-2/7/1
25JEE06 SWEET POTATO
21-JUL-2008 UNSAFE COL
NEEDS FCE
Bum A Food Co. Ltd
Kyeongnam , KR SEA-DO U47-0460987-2/22/1
16WGT21 SNAIL BASED SOUP
21-JUL-2008 FALSE
NEEDS FCE
NO PROCESS
Infopia Co Ltd
Kyunggi , KR SEA-DO 112-3475750-1/1/1
81G--KR 929165555622/TEST KIT FOR AUTO.HEMOGLOBI
22-JUL-2008 NOT LISTED
NO 510(K)
Infopia Co Ltd
Kyunggi , KR SEA-DO 112-3475750-1/2/1
81G--KR 929165555622/TEST CARTRIDGE
22-JUL-2008 NOT LISTED
NO 510(K)
Cosmos Confectionary Co.,Ltd.
Gyeonggido , KR NYK-DO U47-0460734-8/44/1
60LAY63 PAS
23-JUL-2008 NOT LISTED
UNAPPROVED
Nam Yang Intl Co
Seoul , KR NYK-DO UPS-1399199-5/1/1
54ACL90 LIQUID VITAMIN PNC#080081447294
24-JUL-2008 LIST INGRE
Seo Kyoung Vestas Ct Ltd
Seoul , KR NYK-DO 656-0933675-8/1/1
77J--YH EAR PICK W/LIGHT
24-JUL-2008 NOT LISTED
Wang In Food Co Ltd
Jeonranamdo , KR LOS-DO 655-1430142-7/24/1
25JGI26 PICKLED RADISH
24-JUL-2008 NEEDS FCE
NO PROCESS
Hasunjung General Good Co., Ltd.
Gyeonggi-Do, Korea , KR LOS-DO CAY-1006679-0/17/1
16YCE09 SALTED FISH SAUCE (SAE-U) 500G
24-JUL-2008 LIST INGRE
STD IDENT
TRANSFAT
NUTRIT LBL
Jungkyo Foods Co., Ltd\
Gyeonggi , KR SWI-DO 805-0118777-9/16/1
16AGH28 POLLACK DRIED
28-JUL-2008 FILTHY
Samwha Hanyang Foods Co, Ltd
Chungnam , KR SAN-DO D11-0115174-8/11/9
31KCI99 ALOE HONEY TEA (011671)
29-JUL-2008 NEEDS FCE
NO PROCESS
Samwha Hanyang Foods Co, Ltd
Chungnam , KR SAN-DO D11-0115174-8/11/6
31KCI99 GINGER TEA (11099)
29-JUL-2008 NEEDS FCE
NO PROCESS
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO DQ7-0171857-8/2/10
53LD-06 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION;
30-JUL-2008 NOT LISTED
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO DQ7-0171857-8/2/11
53LD-99 OTHER SKIN CARE PREPARATIONS, N.E.C.;LOTION;
30-JUL-2008 NOT LISTED
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO DQ7-0171857-8/2/14
53LC-06 EYE LOTION (EYE MAKEUP PREPARATIONS);CREAM;
30-JUL-2008 NOT LISTED
Somang Cosmetics Co Ltd
Inchon City , KR LOS-DO DQ7-0171857-8/2/18
53LD-06 MOISTURIZING (SKIN CARE PREPARATIONS);LOTION;
30-JUL-2008 NOT LISTED
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO AEK-9520692-2/1/1
53LC-08 COSMETIC CREAM
31-JUL-2008 CSTIC LBLG
Caregen Co Ltd
Gyeongi-Do , KR CIN-DO AEK-9520692-2/1/2
53LC-06 COSMETIC CREAM
31-JUL-2008 NOT LISTED