Refusal Actions by FDA as Recorded in OASIS
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 56BAB52
Importers product description: BENZATHINE BENZYL PENICILLIN FOR EXPORT ONLY, PLEASE REFUSE
Refusal date: 02-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737915-0/1/1/
Carrier: COMPAGNIE MARITIME D'AFFRETEM
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3002806514
Manufacturer Name: Sandoz GmbH
Manufacturer address line 1: 6336 Langkampfen
Manufacturer address line 2:
Manufacturer City: Kufstein
Manufacturer Province/state:
Manufacturer Country: Austria
Product code: 56BDB05
Importers product description: Various Rx (no Rx Prescription)
Refusal date: 29-JUL-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0154540-0/1/2/
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005258785
Manufacturer Name: Bristol Myers Squibb Aeve
Manufacturer address line 1: Tatoiou 102 146 71 N Erythraia
Manufacturer address line 2:
Manufacturer City: N. Erithraia
Manufacturer Province/state:
Manufacturer Country: Greece
Product code: 56CCY65
Importers product description: 862018037385 PROCEF 500MG
Refusal date: 01-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-1358403-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3001258572
Manufacturer Name: Rhenochem Ag
Manufacturer address line 1: 4011
Manufacturer address line 2:
Manufacturer City: Basel
Manufacturer Province/state:
Manufacturer Country: Switzerland
Product code: 56DCK21
Importers product description: GENTAMICIN "FOR EXPORT ONLY" PLEASE REFUSE MERCHANDISE
Refusal date: 14-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737763-4/1/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005392494
Manufacturer Name: Mekophar Chemical Pharmaceutical
Manufacturer address line 1: 297 Ly Thuong Kiet St
Manufacturer address line 2: Dist. 11
Manufacturer City: Ho Chi Minh City
Manufacturer Province/state:
Manufacturer Country: Vietnam
Product code: 56EDB81
Importers product description: Various Rx (no Rx Prescription)
Refusal date: 29-JUL-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0154540-0/1/1/
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006119614
Manufacturer Name: Gl Brochem
Manufacturer address line 1: 519 Zi Yue Rd
Manufacturer address line 2:
Manufacturer City: Shanghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56FXY99
Importers product description: 723849434826 FMOC-ASP (OTBU) -OH
Refusal date: 02-JUL-2008
FDA_District: SAN-DO
Entry/doc/line/sfx: 112-2884450-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006119614
Manufacturer Name: Gl Brochem
Manufacturer address line 1: 519 Zi Yue Rd
Manufacturer address line 2:
Manufacturer City: Shanghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56FYY99
Importers product description: 723849905960 PEPTIDE
Refusal date: 03-JUL-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-3329897-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
Manufacturer FEI: 3006193904
Manufacturer Name: Chengdu Kaijie Bio
Manufacturer address line 1: Rm 303 3f Bldg 1
Manufacturer address line 2:
Manufacturer City: Chengdu
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56FYY99
Importers product description: 8651-3815-1742 SERMORELIN
Refusal date: 11-JUL-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-3377541-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
Manufacturer FEI: 3006119614
Manufacturer Name: Gl Brochem
Manufacturer address line 1: 519 Zi Yue Rd
Manufacturer address line 2:
Manufacturer City: Shanghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56FYY99
Importers product description: 723849905135/PEPTIDE
Refusal date: 22-JUL-2008
FDA_District: SEA-DO
Entry/doc/line/sfx: 112-3329682-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
Manufacturer FEI: 3002114834
Manufacturer Name: Pfizer Propriety Limited
Manufacturer address line 1: 38-42 Wharf Road
Manufacturer address line 2:
Manufacturer City: West Ryde
Manufacturer Province/state: NSW
Manufacturer Country: Australia
Product code: 56ICA76
Importers product description: ZITHROMAX/NO RX/NO ID/PER USE
Refusal date: 30-JUL-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-1676643-6/1/4/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006094247
Manufacturer Name: Research Pharmaceutical Co Ltd
Manufacturer address line 1: 58 Xiangcheng Rd
Manufacturer address line 2:
Manufacturer City: Shanghai
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56ICB76
Importers product description: AZITHROMYCIN TABLET "FOR EXPORT ONLY" PLEASE REFUSE MERCHAND
Refusal date: 14-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0737782-4/3/1/
Carrier: CHINA SHIPPING CONTAINER LINE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003795920
Manufacturer Name: Pfizer Inc
Manufacturer address line 1: 150 E 42nd St
Manufacturer address line 2:
Manufacturer City: New York
Manufacturer Province/state: NY
Manufacturer Country: United States
Product code: 56JAL31
Importers product description: 865811004677 CLEOIN
Refusal date: 16-JUL-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-3367730-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006630045
Manufacturer Name: Pfizer
Manufacturer address line 1: 1157 Quezon Ave 2nd Floor
Manufacturer address line 2:
Manufacturer City: Metro Manila
Manufacturer Province/state:
Manufacturer Country: Philippines
Product code: 56JCF99
Importers product description: CLINDAMYCIN
Refusal date: 02-JUL-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-0948878-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006037082
Manufacturer Name: Nanjing Baijingyu Pharmaceutical Co Ltd
Manufacturer address line 1: No 1 Hanzhong Gate Ave
Manufacturer address line 2:
Manufacturer City: Nanjing
Manufacturer Province/state:
Manufacturer Country: China
Product code: 56KCS10
Importers product description: CHLORAMPHENICOL (CERTIFIABLE);HUMAN - RX/SINGLE INGREDIENT;A
Refusal date: 14-JUL-2008
FDA_District: PHI-DO
Entry/doc/line/sfx: 605-4533090-8/1/1/
Carrier: NYK LINE (NIPPON YUSEN KAISHA
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
Manufacturer FEI: 3006981656
Manufacturer Name: Raje Odeh
Manufacturer address line 1: Po Box 19351
Manufacturer address line 2:
Manufacturer City: Jerusalem
Manufacturer Province/state:
Manufacturer Country: Israel
Product code: 56YCB99
Importers product description: ANTIBIOTICS
Refusal date: 21-JUL-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: AEK-9504271-5/1/1/
Carrier: LUFTHANSA CARGO AG
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED