Refusal Actions by FDA as Recorded in OASIS for Taiwan

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Kimlan Foods Co., Ltd. Tao-Yuan Hsien , TW 1234 LOS-DO 065-1253872-6/1/1 37JGE05 PONLAI SOY SAUCE 1GAL 04-JUN-2008 NEEDS FCE NO PROCESS OSSIAN INTERNAYIONAL CO.,LTD CHANGHUA TW-CHA, TW 509 LOS-DO 065-1250602-0/2/5 21UGE99 COFFEE JELLY 05-JUN-2008 LIST INGRE LACKS FIRM LACKS N/C NUTRIT LBL NEEDS FCE NO PROCESS Abnova Taiwan Corp Jhongli , TW 320 SAN-DO 112-2932580-1/1/1 82D--HL 937337427726 MGC PROTEIN 06-JUN-2008 NOT LISTED REGISTERED NO 510(K) Ever Hope International Co., Ltd. Feng-San City , TW LOS-DO 221-1887746-7/1/1 16AGT51 FROZEN MAHI MAHI FILLET 4/5 10-JUN-2008 FILTHY Ever Hope International Co., Ltd. Feng-San City , TW LOS-DO 221-1886858-1/1/1 16AGT51 FROZEN MAHI MAHI FILLET 6/UP 10-JUN-2008 FILTHY Ever Hope International Co., Ltd. Feng-San City , TW LOS-DO 221-1886301-2/1/1 16AGT51 FROZEN MAHI MAHI FILLET 5/6 10-JUN-2008 HISTAMINE FILTHY Ever Hope International Co., Ltd. Feng-San City , TW LOS-DO 221-1886301-2/1/2 16AGT51 FROZEN MAHI MAHI FILLET 6/UP 10-JUN-2008 HISTAMINE FILTHY United Taiwan Corp. - Chao Plant Chao Chou TW-PIF, TW 910 LOS-DO 065-1252188-8/4/1 24BGE07 RED BEAN PASTE 12-JUN-2008 NEEDS FCE NO PROCESS United Taiwan Corp. - Chao Plant Chao Chou TW-PIF, TW 910 LOS-DO 065-1252188-8/5/1 24BGE07 RED BEAN PASTE 12-JUN-2008 NEEDS FCE NO PROCESS United Taiwan Corp. - Chao Plant Chao Chou TW-PIF, TW 910 LOS-DO 065-1252188-8/6/1 24BGE07 SWEETENED RED BEANS 12-JUN-2008 NEEDS FCE NO PROCESS Bao Lai Food Materials Co., Ltd. Tu Cheng Citty Taipei, TW 236 LOS-DO 065-1247000-3/4/1 30JGH99 TARO FLAVOR POWDER 12-JUN-2008 UNSAFE COL LIST INGRE FALSE LACKS FIRM LACKS N/C NUTRIT LBL OSSIAN INTERNAYIONAL CO.,LTD CHANGHUA TW-CHA, TW 509 LOS-DO 065-1247000-3/5/10 21VGT99 HSIEN TSAO CONC. JUICE 12-JUN-2008 LIST INGRE LACKS FIRM LACKS N/C USUAL NAME NEEDS FCE NO PROCESS Home Jack Co. Hsinchu City , TW LOS-DO 065-1247000-3/7/1 02HGP01 Black Tapioca Pearls 12-JUN-2008 LACKS FIRM LACKS N/C NEEDS FCE NO PROCESS KUANG-HO LYING-IN CO.,LTD. TAIPEI TW-TPE, TW 11157 LOS-DO 063-0062850-7/1/1 37JCE07 COOKING WATER FOR SIMMER CHICKEN 12-JUN-2008 LIST INGRE NEEDS FCE NO PROCESS Sun Ten Pharmaceuticals Taipei , TW LOS-DO BXE-0008671-8/1/3 54ECR99 Red Yeast Rice 12-JUN-2008 UNSAFE ADD How Pin Wel Food Ltd Bei Dow , TW LOS-DO 055-0056009-8/6/1 37JEE23 CURRY SAUCE 12-JUN-2008 NEEDS FCE NO PROCESS Chunghwa Chemical Synthesis & Biotech Co Ltd Taipei , TW SEA-DO 112-3019782-7/1/1 91N--RP 849626701174 SIROLIMUS (RAPAMYCIN) 13-JUN-2008 DIRECTIONS Chin Chi Shun Industrial Co., Ltd. Feng Shan City, Kaohsiung Hsien , TW 1234 SAN-DO 427-7304765-1/2/1 21GGT15 PRUNE (GINGER) 16-JUN-2008 UNSAFE COL FILTHY CYCLAMATE DULCIN SACCHARIN Chin Chi Shun Industrial Co., Ltd. Feng Shan City, Kaohsiung Hsien , TW 1234 SAN-DO 427-7304765-1/2/2 21GGT15 PRUNE (MALTOSE) 16-JUN-2008 UNSAFE COL FILTHY CYCLAMATE DULCIN SACCHARIN Chin Chi Shun Industrial Co., Ltd. Feng Shan City, Kaohsiung Hsien , TW 1234 SAN-DO 427-7304765-1/2/3 21GGT15 PRUNE (PINEAPPLE) 16-JUN-2008 UNSAFE COL FILTHY CYCLAMATE DULCIN SACCHARIN Cleverwave Tech Inc Taoyuan , TW LOS-DO AEK-7749043-7/1/1C 95R--ES GM XP01 Diode Module 17-JUN-2008 FAILS STD NO TAG Cleverwave Tech Inc Taoyuan , TW LOS-DO AEK-7749043-7/1/1B 95R--ES GP-PS07-005 Green Laser Pointer, (Black model per Importer) 17-JUN-2008 FAILS STD NO TAG Cleverwave Tech Inc Taoyuan , TW LOS-DO AEK-7749043-7/1/1A 95R--ES GP-PS02-005 Green Laser Pointer, (Chrome model per Importer) 17-JUN-2008 FAILS STD NO TAG Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/1/1 20AGH04 CRANBERRIES 18-JUN-2008 UNSAFE COL Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/2/1 07YGT99 CRABERRY CASHEW NUT CRISP 18-JUN-2008 UNSAFE COL Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/3/1 07YGT99 DRIED KONJAC 18-JUN-2008 FOREIGN OB Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/4/1 35AGT99 Green Tea Yogurt 18-JUN-2008 LIST INGRE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/6/1 27VCT99 Worcestershire Sauce 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/7/1 37JCT99 BAMBOO SALT RED MOSS 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/8/1 37JCT99 NATURE TASTE SCOLDS THE HOT PEPEPER SAUCE 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/9/1 21JCT16 REGIMEN GOLD JUJUBE JAM 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/15/1 23JET99 MIX NUTS & DRIED FRUITS 18-JUN-2008 UNSAFE COL Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/21/1 27VCT99 BROWN RICE VINEGAR 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/22/1 27VCT99 OLD PINE VINEGAR 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/23/1 27VCT02 CONCENTRATED BROWN RICE VINEGAR 18-JUN-2008 NEEDS FCE Organic Garden Bioscientific Taichung , TW LOS-DO DZ1-3078280-5/25/1 21JCT14 PLUM JELLY 18-JUN-2008 LIST INGRE Weber International Trade Ltd. Yu-Chi Nantou County , TW LOS-DO XXX-0154460-1/2/1A 27VCT99 Plum Fruit Vinegar 18-JUN-2008 FALSE Tsang Lin Industries Corporation Taichung City , TW LOS-DO 880-0069175-3/1/1 33LHT07 FRUITERY JELLY LYCHEE FLAVOR SNACKS 19-JUN-2008 FOREIGN OB Tsang Lin Industries Corporation Taichung City , TW LOS-DO 880-0069175-3/1/2 33LHT07 FRUITERY JELLYSNACKS LYCHEE FLAVOR 19-JUN-2008 FILTHY Tsang Lin Industries Corporation Taichung City , TW LOS-DO 880-0069175-3/1/3 33LHT07 FRUITERY JELLY SNACKS ASSORTED FLAVOR 19-JUN-2008 FILTHY Hong-Ling Foods Industry Co. Ping-Tung TW-PIF, TW 932 SWI-DO WBA-3031610-2/2/1 15BVT06 Boiled salted duck egg - RF Brand 20-JUN-2008 LACKS FIRM NEEDS FCE NO PROCESS Hong-Ling Foods Industry Co. Ping-Tung TW-PIF, TW 932 SWI-DO WBA-3031610-2/2/2 15BVT06 Preserved duck egg - RF Brand. 20-JUN-2008 LACKS FIRM NEEDS FCE NO PROCESS Hong-Ling Foods Industry Co. Ping-Tung TW-PIF, TW 932 SWI-DO WBA-3031610-2/2/3 15BVT06 Boiled Salted Duck Egg - DAF Brand. 20-JUN-2008 LACKS FIRM NEEDS FCE NO PROCESS Hong-Ling Foods Industry Co. Ping-Tung TW-PIF, TW 932 SWI-DO WBA-3031610-2/2/4 15BVT06 Preserved Duck Egg - DAF Brand. 20-JUN-2008 LACKS FIRM NEEDS FCE NO PROCESS Vitalon Foods Co Thaichung , TW SAN-DO 427-7304631-5/1/1 31KHT20 VITALON O'CHA YEN JAP. GREEN TEA 20-JUN-2008 NO PROCESS Vitalon Foods Co Thaichung , TW SAN-DO 427-7304631-5/1/2 31KHT20 VITALON O'CHA YEN GOLDEN OOLONG TEA 20-JUN-2008 NO PROCESS Vitalon Foods Co Thaichung , TW SAN-DO 427-7304631-5/1/3 31KHT20 O'CHA YEN CHIN HSUAN GREEN TEA 20-JUN-2008 NO PROCESS Vitalon Foods Co Thaichung , TW SAN-DO 427-7304631-5/1/4 31KHT20 VITALON O'CHA YEN ICE-BREWED GREEN TEA 20-JUN-2008 NO PROCESS Vitalon Foods Co Thaichung , TW SAN-DO 427-7304631-5/1/5 31KHT20 O'CHA YEN OOLONG TEA 20-JUN-2008 NO PROCESS Ching Huei Trading Co Ltd Taipei Hsientaipei Hsien , TW 24700 CIN-DO UPS-1261429-1/1/1 79O--HS BEAUTY EQUIPMENTS, SKIN MASSAGER-BB-1888+BIO LIGHT 23-JUN-2008 NOT LISTED REGISTERED NO 510(K) Mediland Enterprise Corp Taipei , TW FLA-DO MC2-6055620-4/1/1B 79F--TD surgical lamp 23-JUN-2008 NOT LISTED NO 510(K) Bao Lai Food Materials Co., Ltd. Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/8 30AGT01 STRAWBERRY POWDER 25-JUN-2008 UNSAFE COL Grand Chainly Enterprises Co Ltd Taichung City , TW SWI-DO EO7-0125284-5/7/1 31KGT99 RED TEA 25-JUN-2008 LACKS N/C NO ENGLISH LABELING NUTRIT LBL