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
Unilever De Centroametric S.A. Heredia, Costa Rica , CR FLA-DO BOZ-0006899-5/5/1 27YCI06 Chile Sauce 02-JUN-2008 LIST INGRE NO ENGLISH Embotelladora Nacional S.A. Managua , NI FLA-DO WBK-0026317-6/1/5 29BCT02 MIRANDA ORANGE 10-JUN-2008 LABELING Zeneida Altamirano Managua , NI FLA-DO CCB-0000853-1/2/1 21XGC14 TAMARIND PULP 10-JUN-2008 FILTHY Glaxo Smith Kline San Jose , CR FLA-DO CCB-0000853-1/9/1A 62MBJ08 Cofal Fuerte 120 g. 10-JUN-2008 NO ENGLISH UNAPPROVED Glaxo Smith Kline San Jose , CR FLA-DO CCB-0000853-1/9/1B 62MBJ08 Cofal Fuerte 60 g. 10-JUN-2008 NO ENGLISH UNAPPROVED Laboratorios Zepol S.A. San Jose , CR FLA-DO CCB-0000853-1/9/1C 62MBJ08 Zepol Ointment 10-JUN-2008 NO ENGLISH UNAPPROVED Procter And Gamble S De Rl De Cv Nacalpan , MX 53560 FLA-DO CCB-0000853-1/9/1D 62MBJ08 Vick VapoRub 10-JUN-2008 NO ENGLISH UNAPPROVED Kola Shaler Industrial S.A. Managua , NI FLA-DO 793-0603228-9/5/2A 29BCT20 Ginger Ale Shaler 20-JUN-2008 COLOR LBLG NO ENGLISH Kola Shaler Industrial S.A. Managua , NI FLA-DO 793-0603228-9/5/2B 29BCT60 Shaler Club Soda 20-JUN-2008 COLOR LBLG NO ENGLISH EMBOTELLADORA NACIONAL S.A Managua NI-MN, NI none FLA-DO 793-0603228-9/6/1A 29BGT06 Mirinda Uva Soft Drink 20-JUN-2008 COLOR LBLG NO ENGLISH EMBOTELLADORA NACIONAL S.A Managua NI-MN, NI none FLA-DO 793-0603228-9/6/1B 29BGT06 Rojita Soft Drink (.5L Bottles) 20-JUN-2008 COLOR LBLG NO ENGLISH EMBOTELLADORA NACIONAL S.A Managua NI-MN, NI none FLA-DO 793-0603228-9/6/1C 29BGT06 Rojita Soft Drink (2.5L Bottles) 20-JUN-2008 COLOR LBLG NO ENGLISH Sardinas Sirena Managua NI-MN, NI None FLA-DO 793-0603228-9/1/1 16AEY33 SARDINES W CHILI PEPPER 20-JUN-2008 NEEDS FCE NO PROCESS Sardinas Sirena Managua NI-MN, NI None FLA-DO 793-0603228-9/2/1 16AEY33 SARDINES IN TOMATO SAUCE AND CHILI 20-JUN-2008 NEEDS FCE NO PROCESS Industrias Nacional De Refresco Sa Managua , NI NONE FLA-DO 793-0603228-9/7/1 29BGT50 Coca Cola (.5L Plastic Bottles) 20-JUN-2008 NO ENGLISH Industrias Nacional De Refresco Sa Managua , NI NONE FLA-DO 793-0603228-9/7/2 29BHT02 Fanta Naranja Soft Drink 20-JUN-2008 UNSAFE COL NO ENGLISH