Refusal Actions by FDA as Recorded in OASIS for Colombia

    Manufacturer FEI: 3007141881
    Manufacturer Name: Inser Sa
    Manufacturer address line 1: 12 Calle #39-60
    Manufacturer address line 2:
    Manufacturer's City: Medellin
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 64GCA13
    Importers product description: 865793666727/ESTRADIOL VALERATE 2 MG
    Refusal date: 03-NOV-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4634627-7/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3007123469
    Manufacturer Name: C.I. Premier Ltda
    Manufacturer address line 1: Transversal 16 # 70 - 47
    Manufacturer address line 2:
    Manufacturer's City: Bogotabogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 66VDJ99
    Importers product description: HYPOTHERMIC GEL
    Refusal date: 19-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: WTB-0580941-9/1/1/A
    Carrier: ARROW AIR INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3007123469
    Manufacturer Name: C.I. Premier Ltda
    Manufacturer address line 1: Transversal 16 # 70 - 47
    Manufacturer address line 2:
    Manufacturer's City: Bogotabogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 66VDJ99
    Importers product description: THERMOACTIVE GEL
    Refusal date: 19-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: WTB-0580941-9/1/1/B
    Carrier: ARROW AIR INC.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3002350527
    Manufacturer Name: Productos Basicos E.A.T.
    Manufacturer address line 1: Calle 18 No.7-59 Ofic. 401
    Manufacturer address line 2:
    Manufacturer's City: Pereira
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 21XGD99
    Importers product description: Fzn Lulo Whole 397 g pkgs
    Refusal date: 19-NOV-2008
    FDA_District: SWI-DO
    Entry/doc/line/sfx: 240-3064202-9/1/1/B
    Carrier: SEABOARD MARINE LTD
    Bill of Lading: CAR003N13768
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): PESTICIDES


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (POTATOES WITH FLAVOUR LEMON)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/1/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: 1 ct BBQ flavor, 14 ct chicken falvor, potato chips
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/2/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (PENAUT TO COVER IN FLOUR)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/3/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (PENAUT TO COVER IN CHOCOLATE)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/4/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (POTATOES NATURAL)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/5/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (FRIED POTATOES WITH FLAVOUR MAIZE)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/6/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (RING-SHAPED PASTRY)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/7/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (MIXED SNACK)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/8/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNSAFE COL
               LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (ACHIRAS)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/9/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006033280
    Manufacturer Name: Export Andina Ltda
    Manufacturer address line 1: Avenida El Dorado No 98-50
    Manufacturer address line 2:
    Manufacturer's City: Bogota
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 07AGE99
    Importers product description: SNACKS (FRIED OF CORN)
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: DM4-0231146-6/1/10/
    Carrier: UNITED PARCEL SERVICE
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006543087
    Manufacturer Name: GLORMED COLOMBIA S.A.
    Manufacturer address line 1: MAMONAL KM. 9 ZONA FRANCA
    Manufacturer address line 2:
    Manufacturer's City: CARTAGENA
    Manufacturer Province/state:
    Manufacturer Country: Colombia
    Product code: 80L--YZ
    Importers product description: GLOVE, PATIENT EXAMINATION, VINYL;;
    Refusal date: 25-NOV-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: BEA-9050888-4/1/1/
    Carrier: MITSUI O S K LINES LTD
    Bill of Lading:
    FDA sample analysis: Yes
    FDA record of private lab sample analysis: No
    Charge(s): HOLES