Refusal Actions by FDA as Recorded in OASIS for Ukraine

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/11/1 80F--PF ENEMA BAG 04-FEB-2008 NOT LISTED REGISTERED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/11/2 80F--PF ENEMA BAG 04-FEB-2008 NOT LISTED REGISTERED Pharm Invest Jv Chernovtsy , UA 48052 NYK-DO 940-0169725-2/11/3 80F--PF ENEMA BAG 04-FEB-2008 NOT LISTED REGISTERED Ooo "Rosinka" Kiev Kk Kiev , UA NYK-DO 112-1086338-0/7/1A 29BGT99 FEIJOA 21-FEB-2008 UNSAFE COL LIST INGRE Odessa Can'S Plant Odessa , UA NYK-DO 112-1086338-0/13/2 25FCF99 GOURMET MARROW SPREAD 21-FEB-2008 LIST INGRE NUTRIT LBL NEEDS FCE NO PROCESS