Refusal Actions by FDA as Recorded in OASIS for Colombia
Manufacturer FEI: 3007050604
Manufacturer Name: Universidad De Antioquia
Manufacturer address line 1: Carr 50 No 50-14
Manufacturer address line 2:
Manufacturer's City: Medellin
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 61AIK09
Importers product description: EMETINE SALT SAMPLE FOR LAB. ONLY
Refusal date: 02-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AEK-9585679-1/1/1/
Carrier: DHL AERO EXPRESO S.A.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3004915831
Manufacturer Name: Lab Genfar Sa
Manufacturer address line 1: Parque Industrial Caucadesa 43
Manufacturer address line 2:
Manufacturer's City: Cali
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 62LCB50
Importers product description: 969315247220 Secnidazole
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3944245-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006404285
Manufacturer Name: Procaps S. A.
Manufacturer address line 1: Cr 56 9 32
Manufacturer address line 2:
Manufacturer's City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 61FCN56
Importers product description: 865797632312 CLARITRMICINA 500 MG
Refusal date: 19-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4257019-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3007130294
Manufacturer Name: MARES DE COLOMBIA
Manufacturer address line 1: Carretera Troncal de Occidente
Manufacturer address line 2: Sector La Frutera
Manufacturer's City: Cienaga Magdalena
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 16JGD01
Importers product description: FROZEN WHOLE CLEAN CRAB GUMBO
Refusal date: 19-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 406-0421016-7/1/1/
Carrier: DOLE OCEAN CARGO EXPRESS
Bill of Lading: DOLQSMR00598
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): SALMONELLA
Manufacturer FEI: 3007130294
Manufacturer Name: MARES DE COLOMBIA
Manufacturer address line 1: Carretera Troncal de Occidente
Manufacturer address line 2: Sector La Frutera
Manufacturer's City: Cienaga Magdalena
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 16JGD01
Importers product description: FROZEN WHOLE CLEAN CRAB GUMBO
Refusal date: 19-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 406-0421016-7/1/2/
Carrier: DOLE OCEAN CARGO EXPRESS
Bill of Lading: DOLQSMR00598
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): SALMONELLA
Manufacturer FEI: 3007130294
Manufacturer Name: MARES DE COLOMBIA
Manufacturer address line 1: Carretera Troncal de Occidente
Manufacturer address line 2: Sector La Frutera
Manufacturer's City: Cienaga Magdalena
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 16JGD01
Importers product description: FROZEN WHOLE CLEAN CRAB GUMBO
Refusal date: 19-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 406-0421016-7/1/3/
Carrier: DOLE OCEAN CARGO EXPRESS
Bill of Lading: DOLQSMR00598
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): SALMONELLA
Manufacturer FEI: 3006227895
Manufacturer Name: Tech Bionic Sa
Manufacturer address line 1: Cra 7 N 156 78 Ofic 1603
Manufacturer address line 2:
Manufacturer's City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 77O--AF
Importers product description: 860804374391 Hearing Aid Implant
Refusal date: 24-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2516400-6/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO PMA
Manufacturer FEI: 3005528152
Manufacturer Name: Farmacoop
Manufacturer address line 1: Cll 64a N 94 27
Manufacturer address line 2:
Manufacturer's City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 61FCB56
Importers product description: 862417788920 CLARITROMICIA
Refusal date: 24-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2382653-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005528152
Manufacturer Name: Farmacoop
Manufacturer address line 1: Cll 64a N 94 27
Manufacturer address line 2:
Manufacturer's City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 62KCB10
Importers product description: 862417788920 OMEPRASAL
Refusal date: 24-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2382653-1/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005528152
Manufacturer Name: Farmacoop
Manufacturer address line 1: Cll 64a N 94 27
Manufacturer address line 2:
Manufacturer's City: Bogota
Manufacturer Province/state:
Manufacturer Country: Colombia
Product code: 56BCB03
Importers product description: 862417788920 AMOXICILLIN
Refusal date: 24-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2382653-1/1/3/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004263518
Manufacturer Name: C.I. AGROFRUT S.A.
Manufacturer address line 1: Carretera 54 #75 AB
Manufacturer address line 2: Sur- 220Municipio La Estrella
Manufacturer's City: Medellin
Manufacturer Province/state: Co-Ant
Manufacturer Country: Colombia
Product code: 20GGT99
Importers product description: FROZEN LULO PULP 5 CARTONS
Refusal date: 30-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 900-0054257-2/2/8/
Carrier: KING OCEAN SERVICES LIMITED I
Bill of Lading: CTGN64017014
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): PESTICIDES