Refusal Actions by FDA as Recorded in OASIS for Colombia
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Laboratorios Dermanat S.A.
Cali , CO NOL-DO 112-8874726-6/9/1
53RC-12 862765706769 COSMETIC SKIN CARE
07-NOV-2007 CSTIC LBLG
Ortegon & Ortegon Y Cia S En C
El Espinal - Tolima , CO FLA-DO HG8-0112876-7/1/1
28AGC04 FRESH BASIL
08-NOV-2007 PESTICIDE
Pulpafruit Ltda
Bogota , CO FLA-DO JJ8-6101487-3/8/1
21XGD14 TAMARIND (SUBTROPICAL/TROPICAL FRUIT PULP);PLASTIC, SYNTH;RA
14-NOV-2007 FILTHY
Fenix Holding Ltda
Bogota FN, CO 12345 LOS-DO E69-0806349-0/1/1
89N--ZF BODY VACUUM
16-NOV-2007 REGISTERED
NO 510(K)
Coprucol Ltds
Pereira , CO FLA-DO 900-0051438-1/12/1
03TGT99 PUDING MIX 200 CASES
26-NOV-2007 NO ENGLISH
Coprucol Ltds
Pereira , CO FLA-DO 900-0051438-1/12/2
03TGT99 PUDING MIX 25 CASES
26-NOV-2007 NO ENGLISH
Coprucol Ltds
Pereira , CO FLA-DO 900-0051438-1/13/1
03TGT99 BREAD MIX 200 CASES
26-NOV-2007 NO ENGLISH
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/1
23BGB07 PEANUT LIGHT PROCESSED
30-NOV-2007 AFLATOXIN
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/4
23BGB07 PEANUTS COVERED WITH SESAME SEED
30-NOV-2007 AFLATOXIN
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/6
23BGB07 SALTED PROCESSED PEANUTS
30-NOV-2007 AFLATOXIN
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/2
23BGB07 PEANUTS COVERED WITH SESAME SEED
30-NOV-2007 AFLATOXIN
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/3
23BGB07 SWEETENED PEANUTS
30-NOV-2007 AFLATOXIN
Manitoba Ltda.
Cali , CO SJN-DO N35-0220822-5/1/5
23BGB07 SWEETENED PEANUTS
30-NOV-2007 AFLATOXIN
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/1/1A
66VBB99 Para Huesos Sanos Y Fuertes
30-NOV-2007 NO ENGLISH
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/1/1B
66VBB99 Hepaled
30-NOV-2007 NO ENGLISH
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/2/1A
66VDJ99 Redugel
30-NOV-2007 NO ENGLISH
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/2/1B
66VDJ99 Despigmentador
30-NOV-2007 NO ENGLISH
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/2/1C
66VDJ99 Baba De Caracol
30-NOV-2007 NO ENGLISH
Laboratorios Pronabell Ltda.
Cundinamarca , CO FLA-DO JF7-0059595-8/1/1C
66VBB99 Vigorday
30-NOV-2007 NO ENGLISH