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
Abnova Taiwan Corp
Jhongli , TW 320 SAN-DO 112-2553639-3/1/1
75M--MI 937337425024 PROTEIN
02-JUL-2008 NOT LISTED
NO 510(K)
TAIWAN SHUNTAI FOOD CO., LTD.
TA TSUN TW-CHA, TW 515-45 SAN-DO AJ0-0051975-8/4/1
21GGE15 TEA FLAVORED PRUNE
03-JUL-2008 UNSAFE COL
CYCLAMATE
SACCHARLBL
DULCIN
Tien Young Food Co., LTD.
Shin Chung City TW-TPE, TW 242 LOS-DO K64-5019735-0/12/1
02DGT05 RED YEAST RICE GRAIN CORN MEAL
07-JUL-2008 UNSAFE COL
SAN SHU GONG FOOD CO,LTD.
TAIPEI,HSIEN TW-TPE, TW 236 LOS-DO KM6-0106989-1/7/5
03YGT12 YAM CAKE
07-JUL-2008 UNSAFE COL
LIST INGRE
COLOR LBLG
Bella Co. Ltd.
Taipei , TW 11600 NYK-DO NV3-0021096-4/2/1
53CH-07 COLORS (EYE BLUSH)
10-JUL-2008 COSM COLOR
VE WONG CORPORATION FENG TIEN PLANT
YUNLIN HSIEN TW-YUN, TW 631 LOS-DO KM6-0107732-4/6/1
29AET99 ASPARAGUS DRINK
14-JUL-2008 NEEDS FCE
NO PROCESS
Ocean Beauty Corp.
Taipei , TW LOS-DO 221-1890415-4/1/1
16AGT51 FROZEN MAHI MAHI FILLET 4/5
14-JUL-2008 FILTHY
FU-MING INTERNATIONAL ENTERPRISE LTD.
KAOHSIUNG TW-KHH, TW 802 LOS-DO 224-2901751-4/1/1
16AGD58 FROZEN FARM RAISED TILAPIA
15-JUL-2008 SALMONELLA
FU-MING INTERNATIONAL ENTERPRISE LTD.
KAOHSIUNG TW-KHH, TW 802 LOS-DO 224-2901693-8/1/1
16AGT58 FRZN TILAPIA GUTTED & SCALED FARM RAISED
15-JUL-2008 SALMONELLA
Seven Strong Co., Ltd.
Taipei , TW SAN-DO K80-0945710-3/1/1
54ECT99 DE-TOX GUAVA TEA BAGS
17-JUL-2008 UNAPPROVED
Seven Strong Co., Ltd.
Taipei , TW SAN-DO K80-0945710-3/1/2
54ECT99 DE-TOX GUAVA TEA BAGS
17-JUL-2008 UNAPPROVED
Seven Strong Co., Ltd.
Taipei , TW SAN-DO K80-0945710-3/1/3
54ECT99 COLEGO TUOCHA TEA BAGS
17-JUL-2008 UNAPPROVED
Seven Strong Co., Ltd.
Taipei , TW SAN-DO K80-0945710-3/1/4
54ECT99 COLEGO TUOCHA TEA BAGS
17-JUL-2008 UNAPPROVED
SAN SHU GONG FOOD CO,LTD.
TAIPEI,HSIEN TW-TPE, TW 236 LOS-DO KM6-0107882-7/1/9
03RGT01 YAM CAKE
17-JUL-2008 UNSAFE COL
COLOR LBLG
ALLERGEN
Weber International Trade Ltd.
Yu-Chi Nantou County , TW LOS-DO XXX-0154460-1/2/1B
27VCT99 Mulberry Vinegar
17-JUL-2008 LIST INGRE
Weber International Trade Ltd.
Yu-Chi Nantou County , TW LOS-DO XXX-0154460-1/2/1D
27VCT99 Black Bean Vinegar
17-JUL-2008 LIST INGRE
Weber International Trade Ltd.
Yu-Chi Nantou County , TW LOS-DO XXX-0154460-1/2/1E
27VCT99 Vinegar- Unknown Type
17-JUL-2008 LIST INGRE
Weber International Trade Ltd.
Yu-Chi Nantou County , TW LOS-DO XXX-0154460-1/2/1C
27VCT99 Pineapple Fruit Vinegar
17-JUL-2008 LIST INGRE
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/4
30AGT99 WATERMELON POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/5
30AGT06 PINEAPPLE POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/7
30JGN99 TARO FLAVOR POWDER
18-JUL-2008 UNSAFE COL
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/9
30JGT07 Honeydew Melon Flavor Powder
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/10
30AGT06 MANGO POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/12
35DGT99 EGG PUDDING FLAVOR POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/13
35DGT99 TARO PUDDING FLAVOR POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/14
30AGT01 STRAWBERRY PUDDING POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/15
35DGT99 MANGO PUDDING FLAVOR POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125284-5/2/16
30AGT06 PAPAYA FLAVOR POWDER
18-JUL-2008 UNSAFE COL
COLOR LBLG
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125059-1/3/3
30JGN99 TARO FLAVOR POWDER
21-JUL-2008 UNSAFE COL
Bao Lai Food Materials Co., Ltd.
Tu Cheng Citty Taipei, TW 236 SWI-DO EO7-0125748-9/1/7
30JGN99 TARO FLAVOR POWDER
21-JUL-2008 UNSAFE COL
Cho Chuang Ind
Yung Kan City , TW SEA-DO 112-3271434-8/1/1
53CH-03 865076205803/EYE SHADOW
22-JUL-2008 COSM COLOR
Yuh Ming Enterprise Co., Ltd.
Taipei , TW SAN-DO 427-7303744-7/5/1
37BCP30 HOT BEANCURD, PRESERVED
22-JUL-2008 LIST INGRE
TRANSFAT
NUTRIT LBL
NEEDS FCE
NO PROCESS
Ta Chung Ho Food Product Enterprise Co. Ltd.
Chungho City Taipei Coun , T SAN-DO 427-7304529-1/3/3
21IHT13 Peach Syrup
26-JUL-2008 UNSAFE COL
LIST INGRE
LACKS FIRM
LACKS N/C
Ocean Beauty Corp.
Taipei , TW LOS-DO 221-1891817-0/1/1
16AGD51 FROZEN MAHI MAHI FILLET 6/UP
28-JUL-2008 FILTHY
S&W FOOD RESOURCES CO LTD
TAICHUNG TW-TXG, TW 412 NYK-DO BMY-3009782-0/4/1A
21DGT99 Mango Juice Concentrate
29-JUL-2008 UNSAFE COL
COLOR LBLG
S&W FOOD RESOURCES CO LTD
TAICHUNG TW-TXG, TW 412 NYK-DO BMY-3009782-0/4/1B
21DGT99 Strawberry Juice Concentrate
29-JUL-2008 UNSAFE COL
UNSAFE ADD
COLOR LBLG
Jia Fei Food Co
Paten City , TW LOS-DO K64-5019735-0/6/1
37BCT32 PRESERVED BEANCURD CHUNK IN DRESSING WITH CHILI 208X208X406
29-JUL-2008 NEEDS FCE
NO PROCESS
Jia Fei Food Co
Paten City , TW LOS-DO K64-5019735-0/6/2
37BCT32 PRESERVED BEANCURD CHUNK IN DRESSING WITH CHILI 112X112X311
29-JUL-2008 NEEDS FCE
NO PROCESS
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/2
66VCA99 COLDAN S/NO RX/NO ID/PER USE
30-JUL-2008 UNAPPROVED
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/8
66VCA99 PACOALON/NO RX/NO ID/PER USE
30-JUL-2008 UNAPPROVED
C Y Huang
Taipeitaipei , TW 10671 CIN-DO UPS-1676643-6/1/9
66VCA99 CROMOHEXAL NASAL/NO RX/NO ID/PER USE
30-JUL-2008 UNAPPROVED
One Form Co., Ltd.
Taipei TW-TPE, TW 103 LOS-DO BXE-0010685-4/1/1
54ECR99 Panax Quinquefolius Radix and Plastic Bottles in 2 Drums
31-JUL-2008 PESTICIDES