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
Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/2/1 53EA-02 HAIR SPRAY 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/4/1 53ED-07 HAIR GEL 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/15/1 63RBJ06 TOOTHPASTE 06-JUN-2008 NOT LISTED LACKS N/C INCONSPICU NO ENGLISH Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/4/2 53EC-07 HAIR CREAM 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/9/1 76E--FW TOOTH BRUSH 06-JUN-2008 NOT LISTED DIRECTIONS LACKS FIRM REGISTERED DV NAME Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/10/1 53LD-06 LOTION FOR MEN 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/10/2 53LD-06 LOTION FOR WOMEN 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/10/3 53LD-06 SKINLOTION FOR MEN 06-JUN-2008 CSTIC LBLG Park Young Jib. Seoul , KR BLT-DO J06-0026513-5/10/4 53LD-06 SKINLOTION FOR WOMAN 06-JUN-2008 CSTIC LBLG Haitai Kwangju Factory Gwangju KR-29, KR 500-200 SEA-DO 385-2042851-7/2/4 33EGT06 CANDY MELON FLAVOR 10-JUN-2008 UNSAFE COL FALSE Haitai Chonan 2 Factory Chonan , KR 330-836 SEA-DO 385-2042851-7/3/4 33UGT02 CHEWING GUM EUNDAN BOTTLE MINT FLAVOR 10-JUN-2008 UNSAFE COL FALSE Youngwoo Frozen Co Ltd Jeonbuk , KR SEA-DO 221-4020347-6/1/2 37BGT99 FRIED DUMPLINGS 12-JUN-2008 LIST INGRE ALLERGEN Ionfarms Co., Ltd. Incheon , KR NYK-DO D03-0165191-1/27/1 80L--DQ HERBAL POULTICE FOOT PADS-ALL NATURAL DETOXIFIER. 16-JUN-2008 FALSE Eunsung Global Cor Seoul , KR SEA-DO 112-2821338-8/1/1 53LY-01 865695349027/CLEANSING MACHINE 16-JUN-2008 NOT LISTED REGISTERED Hee Chang Trading Co., Ltd. Busan , KR 1234 SEA-DO 221-4020145-4/6/1 22HGH02 HALF-DRIED PERSIMMONS 17-JUN-2008 FALSE PESTICIDES LABELING Sam Heung Company Hanam City Keyonggi-Do, KR 3210 ATL-DO J50-0103214-1/42/1 16AGT56 DRIED FILEFISH 18-JUN-2008 SALMONELLA Sam Heung Company Hanam City Keyonggi-Do, KR 3210 ATL-DO J50-0103214-1/43/1 16AGT56 ROASTED FILEFISH 18-JUN-2008 SALMONELLA Yiga Inc Chungecheongnam Do , KR LOS-DO 805-0118643-3/4/1 29AHT01 Wildberry Juice Drink/ Boisson 19-JUN-2008 NEEDS FCE NO PROCESS Jungkyo Foods Co., Ltd\ Gyeonggi , KR LOS-DO 805-0118643-3/5/1 45IG-99 Powdered Enzyme Amylase 19-JUN-2008 LIST INGRE FILTHY LACKS N/C Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 SAN-DO D11-0114918-9/11/3 16MGD03 SLICED SQUID (13778) 23-JUN-2008 MFRHACCP SALMONELLA Ceragem Co., Ltd. Cheon-An City , KR CHI-DO EE6-7132442-8/1/1 89I--SA MASSAGER, THERAPEUTIC, ELECTRIC;; 24-JUN-2008 REGISTERED DAEHYUN SHINNONG INC. Jincheon-gun KR-43, KR 365-843 LOS-DO FD2-0188096-6/34/1 54ECT99 CORNUS FRUIT 24-JUN-2008 FILTHY Hee Chang Trading Co., Ltd. Busan , KR 1234 SEA-DO U47-0460173-9/40/1 16MGH03 DRIED SQUID (SLICED) 25-JUN-2008 SALMONELLA Jungkyo Foods Co., Ltd\ Gyeonggi , KR ATL-DO BMT-0019263-0/4/1 16AGH01 DRIED ANCHOVY 26-JUN-2008 FILTHY SALMONELLA Bosung Foods Co Ltd Gyeonggi , KR ATL-DO BMT-0019263-0/4/2 16AGH01 BOILED & DRIED ANCHOVY 26-JUN-2008 FILTHY SALMONELLA Il Hwa Co Ltd Kyonggi-Do , KR ATL-DO BMT-0019346-3/23/1 29BET99 CARBONATED SOFT DRINK 26-JUN-2008 UNSAFE COL Dong-A Circulation Busan , KR CHI-DO AD3-0319219-0/2/1 29AHE99 GREEN TEA DRINK 26-JUN-2008 NEEDS FCE NO PROCESS Dong-A Circulation Busan , KR CHI-DO AD3-0319219-0/3/1 29AHE99 GREEN TEA DRINK 26-JUN-2008 NEEDS FCE NO PROCESS CLEAN FARM CO.,LTD YEASAN-GUN KR-44, KR 340820 CHI-DO AD3-0319219-0/30/1 29AHE99 CORN SILK TEA DRINK 26-JUN-2008 NEEDS FCE NO PROCESS Jayeonwon Food Inc. Seoul KR-11, KR 134-072 LOS-DO CAY-1006006-6/5/1 33EGY06 Snack Candy (Zzondgi) 30-JUN-2008 UNSAFE COL LIST INGRE STD IDENT TRANSFAT NUTRIT LBL Jayeonwon Food Inc. Seoul KR-11, KR 134-072 LOS-DO CAY-1006006-6/1/1 25LGY23 Dried Taro Stem 30-JUN-2008 LIST INGRE LACKS N/C TRANSFAT NUTRIT LBL