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
Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/41/1 16UGT03 ROASTED SQUID 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/42/1 16UGT03 ROASTED SQUID LEGS 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/43/1 16MGT03 SEASONED SQUID SLICED 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/44/1 16UGT03 ROASTED SQUID 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/45/1 16UGT03 ROASTED SQUID 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/46/1 16UGT03 ROASTED SQUID 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 CHI-DO 677-0320270-4/47/1 16UGT03 ROASTED SQUID 07-MAY-2008 MFRHACCP Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 SEA-DO 221-4021113-1/10/1 16MGT03 SQUID, OTHER AQUATIC SPECIES;PLASTIC, SYNTH;PACKAGED FOOD (N Partial Refusal 08-MAY-2008 NUTRIT LBL Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 SEA-DO 221-4021113-1/10/2 16MGT03 SQUID, OTHER AQUATIC SPECIES;PLASTIC, SYNTH;PACKAGED FOOD (N Partial Refusal 08-MAY-2008 NUTRIT LBL Jeong Hwa Foods Co., Ltd. Pohang Kyungbuk-Do, KR 42314 SEA-DO 221-4021113-1/10/3 16MGT03 SQUID, OTHER AQUATIC SPECIES;PLASTIC, SYNTH;PACKAGED FOOD (N Partial Refusal 08-MAY-2008 NUTRIT LBL Cheongjeong-Insam Co Ltd Chung-Nam , KR LOS-DO WRE-0369903-0/1/1 29ACT21 PANAX GINSENG TONIC(KOREAN RED GINSENG TONIC) 12-MAY-2008 NEEDS FCE NO PROCESS Cheongjeong-Insam Co Ltd Chung-Nam , KR LOS-DO WRE-0369903-0/1/3 29ACT21 PANAX GINSENG TONIC(KOREAN RED GINSENG TONIC) 12-MAY-2008 NEEDS FCE NO PROCESS Binggrae Gwangju Plant Gwangju-Si KR-41, KR 464-759 LOS-DO 805-0118429-7/25/1 03HGT07 COOKIES 14-MAY-2008 UNSAFE COL Crown Confectionery Co. Chungbuk , KR LOS-DO 805-0118429-7/30/1 33CGT06 CANDY 14-MAY-2008 UNSAFE COL Crown Confectionery Co. Chungbuk , KR LOS-DO 805-0118429-7/32/1 33EGT99 KOREAN CANDY 14-MAY-2008 UNSAFE COL Crown Confectionery Co. Chungbuk , KR LOS-DO 805-0118429-7/33/1 33CGT06 CANDY 14-MAY-2008 UNSAFE COL Crown Confectionery Co. Chungbuk , KR LOS-DO 805-0118429-7/34/1 33CGT06 CANDY 14-MAY-2008 UNSAFE COL Okchun Agricultural Cooperative Food Processing Choongbuk , KR 373-830 LOS-DO 805-0118429-7/3/1 29AHE99 KOREAN DRINK ALOE FLAVOR 14-MAY-2008 NEEDS FCE NO PROCESS LG Life Sciences Iksan City, Chunbuk-Do , KR 570-350 BLT-DO XXX-0153699-5/1/1 64RBZ18 Eutropin 4 IU 16-MAY-2008 NOT LISTED UNAPPROVED AMORE PACIFIC CORPORATION YONGSAN-GU Kr-11, KR 140-777 LOS-DO AN1-0569065-3/1/38 53LC-03 SULHWASOO SNOWISE CREAM 16-MAY-2008 NOT LISTED CSTIC LBLG AMORE PACIFIC CORPORATION YONGSAN-GU Kr-11, KR 140-777 LOS-DO AN1-0569065-3/1/40 53LD-03 SULHWASOO SNOWISE CREAM 16-MAY-2008 NOT LISTED WellFarm Co.Ltd Eumsung-kun KR-43, KR 369-902 LOS-DO AJA-0117622-7/2/1 25MDT99 GINSENG EXTRACT - EROM RED GINSENG FORTE 19-MAY-2008 NEEDS FCE NO PROCESS SIN YOUNG FOOD COMPANY BUSAN KR-26, KR 612-050 SEA-DO N16-1036985-5/5/1 54FBT99 DRIED ASTER THUMB 20-MAY-2008 FILTHY Dong A Confectionery Co. Busan, Korea , KR SEA-DO N16-1036985-5/8/3 33EGT06 ASSORTED CANDY 20-MAY-2008 UNSAFE COL K J I Industrial Co., Ltd. Busan , KR 702 800 SEA-DO 112-2486899-5/1/1 66VBY99 948350419170/FOOT PATCH 23-MAY-2008 DIRECTIONS Lotte Chilsung Beverage Opo Plant Gyeonggido , KR LOS-DO BMI-1004845-3/1/3 29YGE99 ALOE DRINK, 192CT, 12PK/CT, 1.5L/PK 29-MAY-2008 NEEDS FCE NO PROCESS K J I Industrial Co., Ltd. Busan , KR 702 800 SEA-DO 112-2625250-3/1/1 66VBY99 948350424066/FOREST BANDAGE 30-MAY-2008 DIRECTIONS