Refusal Actions by FDA as Recorded in OASIS for Russia

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/1/1A 33EGT02 SOFT CARAMEL CANDIES 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/2/1 34FGT02 HARD CANDIES FIDGE FLAVORED INDVIDUALLY WRAPPED PACKED LOOSE 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/3/1 34FGT02 CHOCOLATE HARD CANDIES INDIVIDUALLY WRAPPED PACKED LOOSE IN 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/4/1 34FFT01 CHOCOLATE BARS WITH CREAM FILLING 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/5/1A 34FFT01 milk chocolate brandy flavor AOXHOBEHNE 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/5/1B 34FFT01 Milk chocolate bar w/ hazelnut paste 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/6/1 03HFT99 WAFER COOKIES 10-MAR-2008 NO ENGLISH J S C Rot Front Moscow , RU 115184 NYK-DO EG6-1453249-7/7/1 34BFT14 COCOA POWDER 10-MAR-2008 NO ENGLISH Diluaver, Ooo Moscow , RU 113054 SEA-DO BQL-0015208-0/12/2 20CCT14 WILD STRAWBERRY W SUGAR 24-MAR-2008 UNSAFE COL LABELING Diluaver, Ooo Moscow , RU 113054 SEA-DO BQL-0015208-0/12/3 20CCT14 STRAWBERRY W SUGAR 24-MAR-2008 UNSAFE COL LABELING Diluaver, Ooo Moscow , RU 113054 SEA-DO BQL-0015208-0/12/5 20CCT12 RASPBERRY W SUGAR 24-MAR-2008 PESTICIDES Ooo Metiz Mytishchi , RU CIN-DO AEK-9429170-1/1/1 87K--WA SEMI PRODUCTS PROSTHESIS 27-MAR-2008 NOT LISTED NO 510(K)