Refusal Actions by FDA as Recorded in OASIS for Argentina

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Ferrero Argentina Los Cardales , AR 2814 NYK-DO UPS-0872063-1/3/1 34FDT08 KINDER SURPRISE CHOCOLATE EGGS 14-OCT-2008 IMBED OBJT Unknown Unknown , AR ATL-DO XXX-0155457-6/1/1 66VDY99 Various Rx (commercial amounts) over 7,000 tabs (loose/unden 15-OCT-2008 AGR RX Unknown Unknown , AR ATL-DO XXX-0155457-6/1/2 66VDY99 Various Rx (commercial amounts) over 7,000 tabs (pkg/loose / 15-OCT-2008 AGR RX Cassab Ahun S.R.L San Juan , AR 5400 NYK-DO 322-5590482-6/1/1 20BFD10 RAISINS 29-OCT-2008 FILTHY Vital Maycar S.A. Buenos Aires , AR 2950 LOS-DO U33-0017985-0/1/1 24DGE22 PINEAPPLE & SOY MIXED JUICE 31-OCT-2008 LIST INGRE TRANSFAT NUTRIT LBL NEEDS FCE NO PROCESS Vital Maycar S.A. Buenos Aires , AR 2950 LOS-DO U33-0017985-0/2/1 24DGE22 MIXED FRUITS AND SOYBEAN JUICE 31-OCT-2008 NEEDS FCE NO PROCESS Vital Maycar S.A. Buenos Aires , AR 2950 LOS-DO U33-0017985-0/3/1 24DGE22 MIXED ORANGE AND SOY JUICE 31-OCT-2008 LIST INGRE FALSE NEEDS FCE NO PROCESS Vital Maycar S.A. Buenos Aires , AR 2950 LOS-DO U33-0017985-0/4/1 24DGE22 MIXED FRUITS AND SOYBEAN JUICE 31-OCT-2008 LIST INGRE FALSE NEEDS FCE NO PROCESS Vital Maycar S.A. Buenos Aires , AR 2950 LOS-DO U33-0017985-0/5/1 24DGE22 MIXED ORANGE AND SOY JUICE 31-OCT-2008 LIST INGRE FALSE NEEDS FCE NO PROCESS