Refusal Actions by FDA as Recorded in OASIS for Croatia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/1 25QCT99 FUNGI PIECES & STEMS EG MUSHROOM, TRUFFL 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/2 25QCT99 FUNGI PIECES & STEMS EG MUSHROOM, TRUFFL 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/3 25QCT99 FUNGI PIECES & STEMS EG MUSHROOM, TRUFFL 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/4 25PCT02 FUNGI WHOLE EG MUSHROOMS, TRUFFLES, 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/5 25PCT02 FUNGI WHOLE EG MUSHROOMS, TRUFFLES, 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS Zigante Tartufi d.o.o. Buje HR-18, HR 52460 SEA-DO AKU-0012577-4/1/6 25PCT02 FUNGI WHOLE EG MUSHROOMS, TRUFFLES, 07-NOV-2007 NUTRIT LBL NEEDS FCE NO PROCESS