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
SHUN TAI FOOD CO., LTD. CHANG HWA TW-CHA, TW 515 LOS-DO KM6-0105041-2/39/1 21JFT15 PRESERVED PRUNE 04-DEC-2007 UNSAFE COL UNSAFE ADD FILTHY LABELING VE WONG CORPORATION FENG TIEN PLANT YUNLIN HSIEN TW-YUN, TW 631 SEA-DO N16-1034505-3/3/1 21SEE04 GUAVA DRINK 05-DEC-2007 NO PROCESS Laurel Enterprise Corp. Taipei , TW 1234 NYK-DO 315-5151054-3/7/1 37BGD99 GREEN ONION PANCAKE 06-DEC-2007 SALMONELLA Hochico Marine Processing Corp. Su-Ao, I-Lan TW-ILA, TW 270 NYK-DO 594-0182690-0/1/1 16AGD63 FROZEN WHOLE KINGFISH GUTTED 07-DEC-2007 SALMONELLA Bing Han Pharmaceutical Factory Co., Ltd. Kuan Tyen Hsiang TW-TNN, TW 720 SEA-DO N26-0710288-7/1/1 54FBR12 GINSENG POWDER 07-DEC-2007 PESTICIDES Skylark Device & Systems Co. Ltd. Taoyuan , TW NOL-DO 112-0433791-2/2/1 89I--MI 792605285654 MASSAGER 11-DEC-2007 NOT LISTED Kuan Yin Hsiang Pingjhen City,Taoyuan , TW LOS-DO 055-0055695-5/1/1 18BGT03 VEG CHICKEN NUGGET 11-DEC-2007 INSANITARY LACKS FIRM USUAL NAME BANNER INTERNATIONAL CORPORATION TAIPEI TW-TPE, TW 104 LOS-DO 055-0055695-5/2/1 18DGT99 FISH FLAVOUR TOFU (BALL) 11-DEC-2007 LIST INGRE INSANITARY LACKS FIRM LACKS N/C USUAL NAME NUTRIT LBL Ever Spring Foods Supplier Inc. Kaohsiung, , TW 806 LOS-DO 595-4290132-3/1/1A 16JGD04 Frozen Brown Slipper Lobster Tails IQF Size 1/2 11-DEC-2007 FILTHY Ever Spring Foods Supplier Inc. Kaohsiung, , TW 806 LOS-DO 595-4290132-3/1/1B 16JGD04 Frozen Brown Slipper Lobster Tails IQF Size 2/4 11-DEC-2007 FILTHY Ever Spring Foods Supplier Inc. Kaohsiung, , TW 806 LOS-DO 595-4290132-3/1/1C 16JGD04 Frozen Brown Slipper Lobster Tails IQF Size 4/6 11-DEC-2007 FILTHY Master Sauce Co., Ltd. Tai-Chung , TW LOS-DO D52-0923019-7/13/1 37JCT16 BLACK BEAN GARLIC SAUCE 12-DEC-2007 FILTHY Kantry Corp Taipei , TW NONE LOS-DO W69-8009853-8/5/1 29WHE99 FERMENTED RICE DRINK 27-DEC-2007 NEEDS FCE NO PROCESS Kantry Corp Taipei , TW NONE LOS-DO W69-8009853-8/5/2 29WHE99 FERMENTED RICE DRINK 27-DEC-2007 NEEDS FCE NO PROCESS Kantry Corp Taipei , TW NONE LOS-DO W69-8009853-8/7/1 24WHE99 ALOE JUICE 27-DEC-2007 NEEDS FCE NO PROCESS Hivox Biotek Inc Taipei , TW SAN-DO 112-0136601-3/1/1 89L--YG 862523142644 MASSAGER 27-DEC-2007 NOT LISTED NO PMA/PDP NO 510(K) Good Plenty Industrial Co.,Ltd. Taoyuan Hsien,Taiwan , TW LOS-DO 063-0061272-5/24/1 16WGE19 SHARK'S FIN W/RICE SOUP 27-DEC-2007 NEEDS FCE NO PROCESS Good Plenty Industrial Co.,Ltd. Taoyuan Hsien,Taiwan , TW LOS-DO 063-0061272-5/24/2 38AVE99 SLICED ABALONE W/RICE SOUP 27-DEC-2007 NEEDS FCE NO PROCESS Her Cheng Fishery Ltd. Taipei , TW LOS-DO 389-0038874-5/4/1 16AGD51 FROZEN WHOLE MAHI MAHI 27-DEC-2007 HISTAMINE FILTHY Pao Chi Chung Enterprise Co Ltd Taipei , TW LOS-DO D52-0924530-2/17/1 37JGT99 "PAO CHUNG" HOT BEAN SAUCE 31-DEC-2007 INSANITARY