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
Hortex Zaklady Przetworstwa Owocowo-Warzywnego
Lezajsk , PL 1234 NYK-DO 071-0175615-8/1/1
20AGT14 FROZEN STRAWBERRIES
06-OCT-2008 PESTICIDES
Polpharma S.A. Pharmaceutica
Starogard Gdanski , PL 83200 LOS-DO 946-0239387-1/1/1
63AIS02 ALENDRONATE SODIUM (BONE CALCIUM REGULATOR);HUMAN - INVESTIG
15-OCT-2008 UNAPPROVED
Orzech Sp Zoo
Kolbuszowa , PL 36100 CHI-DO 450-0176281-9/35/1
24TCE99 MIXED VEGATABLES NO VINAGAR FCE 13921
27-OCT-2008 NO PROCESS
Orzech Sp Zoo
Kolbuszowa , PL 36100 CHI-DO 450-0176281-9/36/1
24FCE20 CUCUMBERS CONCENTRATE NO VINEGAR
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/78/1
16AEE33 SPARTS IN TOMATO SAUCE FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/79/1
16AEE33 SPRATS IN OIL FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/81/1
16WHE22 FISH SALAD FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/82/1
16AEE21 HERRING FILLETS IN TOMATO SAUCE FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/83/1
16AEE21 HERRING FILLETS IN OIL FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/84/1
16AEE73 MACKEREL FILLETS IN TOMATO SAUCE FCE 13652
27-OCT-2008 NO PROCESS
Graal Sa
Zachodnia , PL CHI-DO 450-0176281-9/85/1
16AEE73 MACKEREL FILLETS IN OIL FCE 13652
27-OCT-2008 NO PROCESS
Zpc Wawel Sa
Krakon , PL NYK-DO 112-4783828-0/2/1
34FDY99 CHOCOLATE COVERED PRALINE WAFER
30-OCT-2008 LIST INGRE
LACKS N/C
NUTRIT LBL