Refusal Actions by FDA as Recorded in OASIS for Poland

   Manufacture Name
   City / Country or region                      District  Entry/Doc/Line/Suffix
   Product Code        Product Description
                          Date                             Reason
Lowell International Polska Sp. Z.Oo Olsztyn , PL NYK-DO DP4-0420814-3/1/1 53LD-06 Olive Moisturizing Cream 06-MAR-2008 CSTIC LBLG Lowell International Polska Sp. Z.Oo Olsztyn , PL NYK-DO DP4-0420814-3/2/7 53LD-06 Eye Make-Up Remover Lotion 06-MAR-2008 UNSAFE COL CSTIC LBLG Lowell International Polska Sp. Z.Oo Olsztyn , PL NYK-DO DP4-0420814-3/2/11 66VCS99 Smoothing Face Lotion & Tonic 06-MAR-2008 NOT LISTED UNAPPROVED Nestle Polska Sp.Zoo Warszawa , PL NYK-DO H60-3012130-4/7/1A 35AFT01 Jelly Goose Berry 17-MAR-2008 UNSAFE COL SULFITELBL LABELING NUTRIT LBL Nestle Polska Sp.Zoo Warszawa , PL NYK-DO H60-3012130-4/7/1B 35AFT01 Jelly Peach 17-MAR-2008 SULFITELBL COLOR LBLG LABELING NUTRIT LBL Nestle Polska Sp.Zoo Warszawa , PL NYK-DO H60-3012130-4/7/1H 35AFT01 Jelly Cherry 17-MAR-2008 UNSAFE COL Energy Cosmetic Lominaki , PL NOL-DO 112-1670787-0/1/1 53LC-10 Repair Complex #1 18-MAR-2008 LABELING Energy Cosmetic Lominaki , PL NOL-DO 112-1670787-0/1/2 53LC-10 799807376162/EMULSION 18-MAR-2008 LABELING Energy Cosmetic Lominaki , PL NOL-DO 112-1670787-0/1/3 65LBJ99 SPF 25 Solaris 18-MAR-2008 NOT LISTED Energy Cosmetic Lominaki , PL NOL-DO 112-1670787-0/1/4 53LD-03 Slim and Shape. 18-MAR-2008 LABELING Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/10/1 25MHT01 CARROT JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/11/1 25MHT99 CARROT APPLE RASPBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/11/2 25MHT99 CARROT APPLE BANANA JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/11/3 25MHT99 CARROT APPLE PEACH JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/11/4 25MHT99 CARROT APPLE STRAWBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/19/1 25MHT01 CARROT JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/20/1 25MHT99 CARROT APPLE RASPBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/20/2 25MHT99 CARROT APPLE BANANA JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/20/3 25MHT99 CARROT APPLE PEACH JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/20/4 25MHT99 CARROT APPLE STRAWBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/30/1 25MHT01 CARROT JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/31/1 25MHT99 CARROT APPLE RASPBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/31/2 25MHT99 CARROT APPLE BANANA JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/31/3 25MHT99 CARROT APPLE PEACH JUICE 26-MAR-2008 NEEDS FCE NO PROCESS Hortex Holding Sa Warszawa , PL 02337 LOS-DO 071-0171654-1/31/4 25MHT99 CARROT APPLE STRAWBERRY JUICE 26-MAR-2008 NEEDS FCE NO PROCESS