Refusal Actions by FDA as Recorded in OASIS for Brazil

    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53ED-99
    Importers product description: 948379405379 HAIRBLOW OUT LOTION
    Refusal date: 05-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-3943106-0/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): LABELING


    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53ED-01
    Importers product description: 948379405379 CONDITIONER
    Refusal date: 05-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-3943106-0/1/2/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): COSM COLOR
               LABELING
               COSMETLBLG


    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53ED-06
    Importers product description: 948379405379 SHAMPOO
    Refusal date: 05-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-3943106-0/2/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): COSM COLOR
               LABELING
               COSMETLBLG


    Manufacturer FEI: 3003411039
    Manufacturer Name: Laboratoria neo quimica com. e ind. ltda
    Manufacturer address line 1: unknown
    Manufacturer address line 2:
    Manufacturer's City: unknown
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 56YAL99
    Importers product description: .
    Refusal date: 09-SEP-2008
    FDA_District: ATL-DO
    Entry/doc/line/sfx: XXX-0150851-5/1/1/
    Carrier:
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3004132792
    Manufacturer Name: EMS Ind. Farm. Ltda Rod SP 101
    Manufacturer address line 1: Km 08
    Manufacturer address line 2: Hortolandia
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 64GDK07
    Importers product description: .
    Refusal date: 09-SEP-2008
    FDA_District: ATL-DO
    Entry/doc/line/sfx: XXX-0150851-5/1/2/
    Carrier:
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3003675563
    Manufacturer Name: Gambro Do Brasil Ltda
    Manufacturer address line 1: Av Eng Luiz Carlos Berrini, 1297
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state: SP
    Manufacturer Country: Brazil
    Product code: 78L--KN
    Importers product description: BLOOD PLASMA CONTROLLER
    Refusal date: 12-SEP-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: AEK-9586082-7/1/1/
    Carrier: AMERICAN AIRLINES
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): REGISTERED


    Manufacturer FEI: 3006087815
    Manufacturer Name: A.A. Couto Transportes Maritimo Ltda
    Manufacturer address line 1: Rua Chile 227
    Manufacturer address line 2:
    Manufacturer's City: Natal
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 16AGC42
    Importers product description: FRESH SWORDFISH WHOLE
    Refusal date: 17-SEP-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: D97-0455097-6/3/1/
    Carrier: TAM LINHAS AEREAS S.A.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): POISONOUS


    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53ED-06
    Importers product description: 948379405758 SHAMPOO
    Refusal date: 19-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4230819-8/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): CSTIC LBLG


    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53ED-03
    Importers product description: 948379405758 ANTI-FRIZE HAIR PRODUCT
    Refusal date: 19-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4230819-8/3/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): CSTIC LBLG


    Manufacturer FEI: 3006706875
    Manufacturer Name: Cadiveu Cosmeticos Com E Expo
    Manufacturer address line 1: Rua Padre Machado 162
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 53LD-03
    Importers product description: 948379405758 DEEP CLEANSING FACE CREAM
    Refusal date: 19-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-4230819-8/2/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): CSTIC LBLG


    Manufacturer FEI: 3005879872
    Manufacturer Name: Comercio E Importacao De Produtosmedico Hospitalares Pprosin
    Manufacturer address line 1: Rua Do Paraiso 45
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 81L--LG
    Importers product description: PLATELET SEPARATION EQUIPMENT
    Refusal date: 22-SEP-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: K51-0064834-1/1/1/
    Carrier: TAM LINHAS AEREAS S.A.
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               REGISTERED


    Manufacturer FEI: 3000245736
    Manufacturer Name: Novartis Biociencias S.A.
    Manufacturer address line 1: Av. Prof. Vicente Rao, 90
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 62BCY08
    Importers product description: 736503995100 Muricalm (Pimetixeno)
    Refusal date: 22-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-2232377-9/2/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3005512963
    Manufacturer Name: Ens Industria Farmaceutica Ltda
    Manufacturer address line 1: Adv Rua Comendador Carlo Mario G
    Manufacturer address line 2:
    Manufacturer's City: Sao Bernardo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 60WCY01
    Importers product description: 736503995100 ALBENDAZOLE
    Refusal date: 22-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-2232377-9/2/2/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3005884208
    Manufacturer Name: Europharma
    Manufacturer address line 1: Av. Ver. Jose Diniz
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 66VCS99
    Importers product description: 862766222735 PANTOCAL 40MG
    Refusal date: 24-SEP-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-2189067-9/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): UNAPPROVED


    Manufacturer FEI: 3005491025
    Manufacturer Name: Valsampa Exp Imp Ltda
    Manufacturer address line 1: 398 Rua Jose Vincente Cavalheiro
    Manufacturer address line 2:
    Manufacturer's City: Sao Paulo
    Manufacturer Province/state:
    Manufacturer Country: Brazil
    Product code: 28GGY99
    Importers product description: PEPPER SAUCE
    Refusal date: 30-SEP-2008
    FDA_District: FLA-DO
    Entry/doc/line/sfx: 279-0241784-2/9/1/
    Carrier: COMPAGNIE MARITIME D'AFFRETEM
    Bill of Lading: BR1390306
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NEEDS FCE
               NO PROCESS