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
Woojin T.N.D Co.
Seoul , KR LOS-DO DQ7-0172076-4/2/1
79K--GX Detox Foot Patch
01-FEB-2008 UNAPPROVED
Sea Foodlife Corporation
Seongnam-Si, Kyungki-Do , KR CHI-DO ASW-1027433-9/4/1
16MGH03 DRIED CUTTLE FISH: (50 CTN/ 40 PACK/ 3.5 OZ)
04-FEB-2008 SALMONELLA
Han Kook Lehrim Inc
Whasung , KR LOS-DO AEF-0010081-0/1/1
54FCY99 DIETRY SUPPLEMENT, GINSENG EXTRACT
04-FEB-2008 NEEDS FCE
NO PROCESS
Snko Co Ltd
Seoul , KR FLA-DO 413-2721908-9/1/1
78L--ST OQ RING
05-FEB-2008 NOT LISTED
REGISTERED
NO 510(K)
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008906-1/6/1
53ID-02 MOUTH WASH
06-FEB-2008 CSTIC LBLG
Mukunghwa Cooperation
Kyunggi Do , KR LOS-DO CAY-1003434-3/74/1B
66VBY99 BAMBOO SALT WHITE MINT TOOTHPASTE
06-FEB-2008 NOT LISTED
Lee'S Co., Ltd.
Busan , KR LOS-DO CAY-1003434-3/96/1
66YBY99 MOXA
06-FEB-2008 NOT LISTED
DIRECTIONS
AMORE PACIFIC CORPORATION
YONGSAN-GU Kr-11, KR 140-777 LOS-DO AN1-0568230-4/1/4
53LC-03 IOPE WHITE CREAM
11-FEB-2008 UNAPPROVED
Dong-A Otsuka Circulation
Busan , KR LOS-DO CAY-1003434-3/31/1
29BGY99 ORAN-C ORANGE
14-FEB-2008 UNSAFE COL
LIST INGRE
COLOR LBLG
TRANSFAT
NUTRIT LBL
Dong-A Otsuka Circulation
Busan , KR LOS-DO CAY-1003434-3/32/1
29BGY99 ORAN-C GRAPE
14-FEB-2008 UNSAFE COL
COLOR LBLG
TRANSFAT
NUTRIT LBL
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/1/1
53LD-06 AC CARE T.LAB TONER
20-FEB-2008 NOT LISTED
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/1/2
53LD-06 AC CARE T.LAB EMULSION
20-FEB-2008 NOT LISTED
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/1/3
53LD-06 AC CARE T.LAB SERUM
20-FEB-2008 NOT LISTED
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/2/1
53FD-01 HERB COLOR CREAM # 1
20-FEB-2008 LABELING
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/2/2
53FD-01 HERB COLOR CREAM #2
20-FEB-2008 LABELING
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/4/1
53CK-06 ADELIUM TRENDY MASCARA
20-FEB-2008 LABELING
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/4/2
53CK-06 AZN HAIR MASCARA # NATURAL BLACK
20-FEB-2008 LABELING
Dong Sung Pharm. Co
Seoul , KR 1234 LOS-DO WRE-0355495-3/4/3
53CK-06 AZN HAIR MASCARA # DARK BROWN
20-FEB-2008 LABELING
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/8/1A
53GD-05 Tasty Lip Cream S F M
25-FEB-2008 CSTIC LBLG
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/8/1B
53GD-05 Tasty Lip Cream UV
25-FEB-2008 CSTIC LBLG
Daiso Industries Co., Ltd.
Higashihiroshima , JP 739-0008 SEA-DO ANP-0009137-2/148/1D
86H--OI EYEGLASSES Invoice Line 227
25-FEB-2008 NOT LISTED