Refusal Actions by FDA as Recorded in OASIS for Philippines

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Fil-Choice Food Industries, Inc. Malabon City , PH 1470 SAN-DO 427-7301676-3/15/1 29BCT09 ROYAL TRU ORANGE SOFTDRINK 03-FEB-2008 UNSAFE COL LIST INGRE Fil-Choice Food Industries, Inc. Malabon City , PH 1470 SAN-DO 427-7301676-3/15/2 29BHT09 ROYAL TRU ORANGE SOFTDRINK 03-FEB-2008 UNSAFE COL LIST INGRE Eng Bee Tin / Hopia King Manila , PH SAN-DO J14-0060181-8/1/1 03RGT01 HOPIA 04-FEB-2008 UNSAFE COL Aling Conching Native Products Pampanga , PH LOS-DO 277-0116542-8/1/1 02HGT01 ALING CONCHING TAPIOCA PEARL 08-FEB-2008 UNSAFE COL Davseatic Enterprise Co. Inc. Davao City , PH LOS-DO W21-0550644-8/2/1 16AGD42 FROZEN SWORDFISH STEAKS 08-FEB-2008 POISONOUS Organonn Phillipines Makati , PH SAN-DO 112-0981937-7/1/1 64LAC02 862824250396 MEDICATION 08-FEB-2008 UNAPPROVED D'World 2000 Enterprises Corporation Quezon PH-NOTA, PH 1104 SAN-DO D11-0113389-4/11/2 50ACT01 FOOD FLAVORING (STRAWBERRY RED) 08-FEB-2008 UNSAFE COL D'World 2000 Enterprises Corporation Quezon PH-NOTA, PH 1104 SAN-DO D11-0113389-4/11/3 50ACT01 FOOD FLAVORING (VIOLET) 08-FEB-2008 UNSAFE COL D'World 2000 Enterprises Corporation Quezon PH-NOTA, PH 1104 SAN-DO D11-0113389-4/11/4 50ACT01 FOOD FLAVORING (EGG YELLOW) 08-FEB-2008 UNSAFE COL D'World 2000 Enterprises Corporation Quezon PH-NOTA, PH 1104 SAN-DO D11-0113389-4/11/5 50ACT01 FOOD COLORING (ORANGE) 08-FEB-2008 UNSAFE COL Mercury Drug Corp. Manila , PH SEA-DO 112-1209593-2/3/1 65VCY15 862824356868 DIAZEPAM 11-FEB-2008 UNAPPROVED Mofel'S Food International Metro Manila , PH SEA-DO EH5-0040488-2/18/1 16AGT21 DRIED HERRING 12-FEB-2008 INSANITARY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/2/3 16AGT45 8 OZ YELLOWFIN TUNA STEAKS 15-FEB-2008 FILTHY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/1/1 16AGT45 FRESH CUT SAKU TUNA 15-FEB-2008 FILTHY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/2/1 16AGT45 YELLOWFIN TUNA LOIN, 3-5# 15-FEB-2008 FILTHY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/2/2 16AGT45 6 OZ YELLOWFIN TUNA STEAKS 15-FEB-2008 FILTHY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/2/4 16AGT45 10 OZ YELLOWFIN TUNA STEAKS 15-FEB-2008 FILTHY Mommy Gina Tuna Resources (MGTR), Inc General Santos City Ph-Das, PH 9500 SEA-DO 231-6271839-2/2/5 16AGT45 4 OZ YELLOWFIN TUNA STEAKS 15-FEB-2008 FILTHY REGENT FOODS CORPORATION PASIG CITY PH-NOTA, PH 1601 NYK-DO 417-0248193-2/19/1 07BGT02 CORN SNACKS 15-FEB-2008 UNSAFE COL Hopia Bakery Manila , PH LOS-DO BDD-0773525-7/2/2 02DGT10 GLUTINUOS RICE 15-FEB-2008 UNSAFE COL COLOR LBLG Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/1 16AGT45 TUNA STEAK SAKU AAA 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/2 16AGT45 TUNA STEAK SAKU BEAA 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/3 16AGT45 TUNA STEAK SAKU (1 LB/PK) C3 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/4 16AGT45 TUNA STEAK SAKU C2 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/5 16AGT45 TUNA STEAK SAKU L2 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/6 16AGT45 TUNA STEAK SAKU-TRIANGULAR TAIL CUT A3 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173414-1/1/7 16AGT45 TUNA STEAK SAKU-3RD LAYER SAKU A4 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173945-4/1/3 16AGT45 TUNA STEAK SAKU (1 LB/PK) C3 21-FEB-2008 HISTAMINE Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0173945-4/1/5 16AGT45 TUNA STEAK SAKU L2 21-FEB-2008 HISTAMINE Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/1 16AGT45 CO-TREATED TUNA STEAK SAKU AAA 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/2 16AGT45 CO-TREATED TUNA STEAK SAKU BEAA 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/3 16AGT45 CO-TREATED TUNA STEAK SAKU C3 (1LB/PK) 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/4 16AGT45 CO-TREATED TUNA STEAK SAKU C2 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/5 16AGT45 CO-TREATED TUNA STEAK SAKU L2 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/6 16AGT45 CO-TREATED TUNA STEAK SAKU-TRIANGULAR TAIL CUT A3 21-FEB-2008 FILTHY Philippine Cinmic Industrial Corporation General Santos City PH-NOTA, PH 9500 LOS-DO HK1-0174973-5/1/7 16AGT45 CO-TREATED TUNA STEAK SAKU-3RD LAYER SAKU A4 21-FEB-2008 FILTHY Hopia Bakery Manila , PH LOS-DO BDD-0773525-7/1/5 03RGT02 PURPLE YAM CAKE 21-FEB-2008 UNSAFE COL Hopia Bakery Manila , PH LOS-DO BDD-0773525-7/1/6 03RGT02 PURPLE YAM CAKE - DICE 21-FEB-2008 UNSAFE COL Hopia Bakery Manila , PH LOS-DO BDD-0773525-7/1/7 03RGT02 PURPLE YAM & PASTILLAS CAKE COMBI 21-FEB-2008 UNSAFE COL Hopia Bakery Manila , PH LOS-DO BDD-0773525-7/1/8 03RGT02 PURPLE YAM & CHEESE CAKE COMBI 21-FEB-2008 UNSAFE COL COLOR LBLG Ecco Food Corp. Kaloocan City , PH SAN-DO 427-7301218-4/10/9 03JHT09 FILLIPINAS WAFER STICK STRAWBERRY 22-FEB-2008 UNSAFE COL Golden Hands Manufacturing Corp. Metro Manila , PH LOS-DO 277-0117005-5/26/1 21SCE24 SUGAR PALMFRUIT IN SYRUP 25-FEB-2008 UNSAFE COL Golden Hands Manufacturing Corp. Metro Manila , PH LOS-DO 277-0117005-5/27/1 21SCE24 SUGAR PALMFRUIT IN SYRUP (RED) 25-FEB-2008 UNSAFE COL Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117006-3/33/1 28LHT99 SAVOR SEASONING -BARBEQUE 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117006-3/34/1 28LHT99 SAVOR SEASONING-CALAMANSI 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117006-3/35/1 28LHT99 SAVOR SEASONING-CHILIMANSI 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117006-3/36/1 28LHT99 SAVOR SEASONING-CLASSIC 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117006-3/37/1 28LHT99 SAVOR SEASONING-GARLIC 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117007-1/30/1 28LHT99 SAVOR SEASONING-CALAMANSI 25-FEB-2008 NEEDS FCE NO PROCESS Rm Foods,Inc. Bulancan , PH LOS-DO 277-0117007-1/31/1 28LCT99 SAVOR SEASONING-CLASSIC 25-FEB-2008 NEEDS FCE NO PROCESS Dowalex Transport Services Makatimakati , PH 1200 CIN-DO 110-1730113-2/1/1 66VCA99 FENOFIBRATE LIPANTHYL SUPRA 160MG,RX, US CIT, PERUSE 26-FEB-2008 UNAPPROVED Dowalex Transport Services Makatimakati , PH 1200 CIN-DO 110-1730113-2/1/2 66VCA99 TELMISARTAN HYFROCHLOROTHIAZIDE 40MG, RX, US CIT, PER USE 26-FEB-2008 UNAPPROVED Angel Seafood Corp. Santos City , PH NYK-DO 906-0786407-2/7/1 16AGT45 FROZEN AHI TUNA STEAKS 26-FEB-2008 FILTHY Fil-Choice Food Industries, Inc. Malabon City , PH 1470 SAN-DO 427-7301676-3/3/1 21SCI24 TROPICS PALM FRUIT GREEN 26-FEB-2008 UNSAFE COL Fil-Choice Food Industries, Inc. Malabon City , PH 1470 SAN-DO 427-7301676-3/3/4 21SCI24 TROPICS PALM FRUIT GREEN 26-FEB-2008 UNSAFE COL Escaba Food Products San Pablo City , PH SAN-DO 427-7301054-3/7/1 37BCE24 UFC MIXED FRUIT & BEANS 26-FEB-2008 SULFITELBL Splash Corporation Valenzuela City , PH LOS-DO 277-0117007-1/36/1 53LD-03 EXTRADERM WHITE & SMOOTH EXFOLIANT NO.1 MILD 29-FEB-2008 NOT LISTED Splash Corporation Valenzuela City , PH LOS-DO 277-0117007-1/37/1 53LD-03 EXTRADERM WHITE & SMOOTH EXFOLIANT NO.2 MODERATE 29-FEB-2008 NOT LISTED