Refusal Actions by FDA as Recorded in OASIS for Thailand

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
K.L. Interfood Co., Ltd. Bangkok Th-10, TH 10400 NWE-DO 442-7648408-4/1/1 21TGH14 DRIED TAMARIND 04-MAR-2008 FILTHY Thai Agri Foods Public Co., Ltd. Samutprakarn Samutprakarn, TH 10540 NYK-DO KM6-0035229-8/1/2 24WEE41 CANNED YANANG LEAVES EXTRACT 04-MAR-2008 UNSAFE COL Thai-Lee Agriculture Co Ltd Tungwaddorn, Sathorn,Bangkok , TH 10120 LOS-DO 555-0383391-9/1/1 16YCE13 SUNLEE BRAND OYSTER SAUCE 714X505X812 07-MAR-2008 NO PROCESS Young & Sweet Skin Care Paris , FR ATL-DO XXX-0151310-1/1/2 64APU20 Papaya Soap (Whitening w/ Triclosan) & Garlic Shampoo sample 13-MAR-2008 DIRECTIONS DRUG NAME Pond's Chemical Thailand R.O.P. Bangkok , TH 5210830 ATL-DO XXX-0152339-9/2/1 56ACB10 Penicillin G (Potassium Crystalline (500,000 units) Tablets 13-MAR-2008 UNAPPROVED PA- Siam Intertrade Co. Ltd. Bangkok , TH 10120 LOS-DO 277-0117355-4/6/1 24HGT08 DRIED RED CHILI 13-MAR-2008 SALMONELLA Asia Jumbo Industry Co., Ltd. Samutprakarn , TH LOS-DO 880-0066799-3/5/1 33EGT06 CANDY 19-MAR-2008 UNSAFE COL COLOR LBLG Asia Jumbo Industry Co., Ltd. Samutprakarn , TH LOS-DO 880-0066799-3/5/3 33EGT06 CANDY 19-MAR-2008 UNSAFE COL COLOR LBLG Asia Jumbo Industry Co., Ltd. Samutprakarn , TH LOS-DO 880-0066799-3/5/2 33EGT06 CANDY 19-MAR-2008 UNSAFE COL COLOR LBLG I.T. FOODS INDUSTRIES CO.,LTD. Muang, Samutsakorn Th-74, TH 74000 LOS-DO HK1-0175858-7/1/3 16AGT52 GOURAMI FISH GUTTED 21-MAR-2008 SALMONELLA Bds Express Bangkok , TH 10400 LOS-DO MH7-6008993-7/1/1 54FBH99 CHARMING PLUS HERBAL JUICE (352 cartons) & 13 cartons of Cat 24-MAR-2008 UNAPPROVED Chef'S Choice Foods Manufacturer Co., Ltd. Nondaburi Banggruay, TH 11130 DET-DO BGK-0025337-8/16/1 30YEN02 COCONUT MILK BEVERAGE BASE 26-MAR-2008 PRESRV LBL LACKS FIRM LABELING NUTRIT LBL NO PROCESS Leng Heng Agri Food Co Ltd. Sawabngha , TH LOS-DO 880-0068112-7/2/1 24THP20 SOUR PICKLED GREEN MUISTARD 28-MAR-2008 NEEDS ACID NEEDS FCE