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
Mei Kuan Foods Co Ltd
Chang Hwa Hsien , TW LOS-DO 880-0066488-3/4/1
21SGT05 TW PRESERVED MANGO SLICE
07-JAN-2008 UNSAFE COL
CYCLAMATE
SACCHARLBL
DULCIN
Mei Kuan Foods Co Ltd
Chang Hwa Hsien , TW LOS-DO 880-0066488-3/5/1
21GGT14 TW WINE PLUM
07-JAN-2008 UNSAFE COL
CYCLAMATE
SACCHARLBL
DULCIN
Real Biotech Corporation
Taipei , TW FLA-DO 231-0285859-7/1/1
82L--RM COMPOSITE DIAGNOSTIC OR LABORATORY REAGENTS
08-JAN-2008 REGISTERED
NO 510(K)
Kantry Corp
Taipei , TW NONE LOS-DO W69-8010361-9/1/1
22KHE99 PLANT JUICE
08-JAN-2008 NEEDS FCE
NO PROCESS
Kantry Corp
Taipei , TW NONE LOS-DO W69-8010361-9/5/1
21VCE20 STAR FRUIT JUICE
08-JAN-2008 NEEDS FCE
NO PROCESS
Kantry Corp
Taipei , TW NONE LOS-DO W69-8010361-9/8/1
21JGH14 PLUM CANDY
08-JAN-2008 UNSAFE COL
CYCLAMATE
SACCHARLBL
DULCIN
SACCHARIN
Kantry Corp
Taipei , TW NONE LOS-DO W69-8010361-9/16/1
31KGE02 ORGANIC WHITE GOURD TEA
08-JAN-2008 NEEDS FCE
NO PROCESS
Transverse Industries Co., Ltd.
Taipei , TW . LOS-DO 231-5717213-4/1/1B
95L--22 TI-311GSI LASER POINTERS
09-JAN-2008 NO REGISTR
Chirogate International Inc.
Taipei , TW 5678 FLA-DO E41-0056420-9/1/1
65KIS99 BIMATOPROST (ON DRY ICE)
14-JAN-2008 NOT LISTED
Sheng Chun Tang Pharmaceutical Industrial Co., Ltd.
Yuan Kang City, Tainan , TW 710 LOS-DO 349-0895644-3/1/18
54FAW99 PLASTRUM TESTUDINIS
15-JAN-2008 DIET INGRE
FU-MING INTERNATIONAL ENTERPRISE LTD.
KAOHSIUNG TW-KHH, TW 802 SAN-DO DZ1-0361139-5/1/1
16AGT58 FROZEN TILAPIA GUTTED/SCALED, IQF (FARM RAISED), SIZE 550/75
15-JAN-2008 SALMONELLA
Beyoung Internatio
Taoyuan , TW SEA-DO 112-0706233-5/1/1
66PBJ99 929067186712 SUNSCREEN
16-JAN-2008 NOT LISTED
Spark Gold Co
Taipei , TW 114 SAN-DO 112-0032280-1/1/1
95R--ES 861152818041 LASER POINTER
17-JAN-2008 NO REGISTR
Acula Technology Corp
Taoyuan Hsien , TW 33800 FLA-DO 554-3421220-9/6/1
94V--07 AQ-09 9 CRT MONITOR
18-JAN-2008 NO REGISTR
Acula Technology Corp
Taoyuan Hsien , TW 33800 FLA-DO 554-3421220-9/5/1
94V--07 AQ-09 9" CRT MONITOR
18-JAN-2008 NO REGISTR
T.G.B. United Enterprise Co
Tainan Hsien , TW CHI-DO BTF-0012944-1/1/1
53CH-03 EYE SHADOW MAKE-UP
23-JAN-2008 UNSAFE COL
Fang Lung Vegetable Agricultural Co. Ltd.
Ping Tung , TW NYK-DO 510-5749462-0/1/1
23KGN03 FROZEN SOY BEANS
23-JAN-2008 PESTICIDES
Jellico Co, Ltd.
Taichung City , TW NYK-DO KM6-0034321-4/6/1
35AGT01 MIXED KONJAC JELLY STICK
24-JAN-2008 FILTHY
TOMAX ENTERPRISE CO.,LTD.
TAICHUNG TW-TXG, TW 407 SAN-DO 224-3066263-9/3/2
28KGT99 JENROFEN POWDER FOR STEAMED MEAT - FIVE SPICE
24-JAN-2008 SALMONELLA
Ossian International Co Ltd
Chang Hua , TW SAN-DO 961-0042121-1/10/1
23FHE05 COCONUT MEAT (GREEN APPLE FLAVOR)
24-JAN-2008 UNSAFE COL
LIST INGRE
NEEDS FCE
NO PROCESS
Ossian International Co Ltd
Chang Hua , TW SAN-DO 961-0042121-1/10/2
23FHE05 COCONUT MEAT (LYCHEE FLAVOR)
24-JAN-2008 NEEDS FCE
NO PROCESS
Ossian International Co Ltd
Chang Hua , TW SAN-DO 961-0042121-1/10/3
23FHE05 COCONUT MEAT (PINEAPPLE FLAVOR)
24-JAN-2008 UNSAFE COL
LIST INGRE
NEEDS FCE
NO PROCESS
Shianlin Frozen Foods Processing Plant
Chiayih , TW 800 SAN-DO AQZ-0252212-9/1/1
16XGD99 FROZEN WHOLE ROUND MILKFISH (FARM RAISED) IQF IWP 500/600GMS
24-JAN-2008 SALMONELLA
Daison Industries Co Ltd
Hiroshima-Ken , JP 739-8501 SEA-DO ANP-0008903-8/4/1B
53GD-05 HYALURONIC ACED LIP CREAM
31-JAN-2008 CSTIC LBLG
Huang Chi Frozen Food Factory Co., Ltd.
Kaohsiung , TW 1234 SAN-DO 597-0150257-3/1/3
16AAD58 FROZEN IQF TILAPIA
31-JAN-2008 SALMONELLA