Refusal Actions by FDA as Recorded in OASIS for Nicaragua

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Kola Shaler Industrial S.A. Managua , NI FLA-DO 745-0033366-6/1/2 29BHY01 SOFT DRINK 07-JAN-2008 UNSAFE COL Kola Shaler Industrial S.A. Managua , NI FLA-DO 745-0033402-9/1/2 29BHY01 SOFT DRINK 07-JAN-2008 UNSAFE COL Flora Matea Oetiz Torrez Somoto , NI FLA-DO JJ8-6101613-4/1/1 03HGT99 CORN COOKIES 10-JAN-2008 FILTHY USUAL NAME NUTRIT LBL Exportacion "El Carmen" Raquel Del Carmen Masaya, Nicaragua , NI FLA-DO T94-0047356-5/1/1 29BEY50 SODAS/COCA COLA 12OZ. 18-JAN-2008 FILTHY NUTRIT LBL Carlos Vargas Managua , NI NOL-DO 112-1003941-1/1/1 76E--LM 863670122474/VENEER 22-JAN-2008 NOT LISTED La Cooperativa San Francisco De Asis, R.L. Camoapa , NI 1234 FLA-DO E84-0051394-9/1/1 12BFO13 CHEESE 25-JAN-2008 MFR INSAN Cereales El Ranchito Masaya , NI FLA-DO 745-0033868-1/2/1 30YGT99 Elaborada Con El Mejor Maiz de Nic 29-JAN-2008 LIST INGRE FILTHY LACKS FIRM LACKS N/C NO ENGLISH Mead Johnson De Mexico/Bristol Myers de Mexico S.A. de C.V. Ciudad Delicias Chihuahua, MX FLA-DO 745-0033868-1/2/2 30YGT99 Strawberry and Vanilla Sustagen 29-JAN-2008 COLOR LBLG NO ENGLISH NUTRIT LBL Cereales El Ranchito Masaya , NI FLA-DO 745-0033868-1/2/3 30YGT99 Dos Pinos Leche Pinito 29-JAN-2008 NO ENGLISH NUTRIT LBL Industrias Alimenticias "Dona Tina" Managua , NI FLA-DO 745-0033868-1/6/1B 45DG-99 Frambuesa ( Strawberry-Raspberry Red colorant for baking-coo 29-JAN-2008 UNSAFE COL NO ENGLISH Industrias Alimenticias "Dona Tina" Managua , NI FLA-DO 745-0033868-1/6/1C 28C--51 Vanilla Extract and Flavorings 29-JAN-2008 UNSAFE ADD NO ENGLISH NUTRIT LBL Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1F 16AEF45 Canned Tuna / Atun Light Sardimar 29-JAN-2008 NEEDS FCE NO PROCESS Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1G 16AEF33 Canned Sardines / La Sirena 29-JAN-2008 NEEDS ACID NO PROCESS Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1O 53JY-01 Mennan - Baby Magic Soap 29-JAN-2008 CSTIC LBLG Glaxo Smith Kline Guatemala , GT FLA-DO 745-0033868-1/6/1P 66VDJ99 COFAL - Fuerte Cream 29-JAN-2008 NO ENGLISH Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1Q 66VDJ99 Diclofenac Sodico - Anti - Inflamatory 29-JAN-2008 NO ENGLISH Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1R 66VDJ99 Higado Sanil - 29-JAN-2008 NO ENGLISH Industrias Alimenticias "Dona Tina" Managua , NI FLA-DO 745-0033868-1/6/1D 27VGT99 Vinagre Tinto 29-JAN-2008 NO ENGLISH NUTRIT LBL Industrias Alimenticias "Dona Tina" Managua , NI FLA-DO 745-0033868-1/6/1E 27YCT01 Natura's KETCHUP 29-JAN-2008 NO ENGLISH NUTRIT LBL Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1H 23MGT99 Semilla de Jicaro Calabaza - edible seed, rece, cinnamon 29-JAN-2008 NO ENGLISH NUTRIT LBL Alimentos Industriales de Nicaragua S.A. Managua NI-MN, NI 50505 FLA-DO 745-0033868-1/6/1I 05AFT04 Quaker Instant Wheat 29-JAN-2008 NO ENGLISH NUTRIT LBL Nestle Guatemala S A Guatemala City , GT FLA-DO 745-0033868-1/6/1L 38HGT27 Maggi Creama Tomate dried soup mix 29-JAN-2008 NO ENGLISH NUTRIT LBL Alimentos Kern De Guatemala Sa Quatemala City , GT FLA-DO 745-0033868-1/6/1M 03MGT99 Chiky Cookies - Chocolate & Vanilla flavor 29-JAN-2008 NO ENGLISH NUTRIT LBL Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1J 33JGT99 Unknown Food Product in small baggies / No idenification 29-JAN-2008 UNSAFE COL LIST INGRE COLOR LBLG LACKS FIRM LACKS N/C NUTRIT LBL Maria Elena Gutierrez Masaya , NI FLA-DO 745-0033868-1/6/1K 02JGT01 Presto Cebada drink mix 29-JAN-2008 UNSAFE COL LIST INGRE COLOR LBLG LACKS FIRM LACKS N/C NUTRIT LBL El Caracol Invenisa Managua , NI FLA-DO 745-0033868-1/6/1N 02AGT02 Cebada Molida Rosada 29-JAN-2008 UNSAFE COL LIST INGRE COLOR LBLG LACKS FIRM LACKS N/C NUTRIT LBL