Refusal Actions by FDA as Recorded in OASIS for Germany
Manufacturer FEI: 3005760145
Manufacturer Name: Zambon Gmbh
Manufacturer address line 1: Heinrich Hertz Str 13
Manufacturer address line 2:
Manufacturer's City: Kerpen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 63BCY30
Importers product description: 863648796161 Theophylline Bruneau
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3780528-1/2/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005224455
Manufacturer Name: Denk Pharma
Manufacturer address line 1: 816575 Muenchen
Manufacturer address line 2:
Manufacturer's City: Munich
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62LBN50
Importers product description: 866434056340 METFORMIN 500. MG
Refusal date: 03-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4141252-0/3/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3005314505
Manufacturer Name: Sandoz International Gmbh
Manufacturer address line 1: Industriestrausse 25
Manufacturer address line 2:
Manufacturer's City: Holkzkirchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62CCP65
Importers product description: 866434056340 LISOPRESS 20.MG
Refusal date: 03-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4141252-0/3/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 1000603905
Manufacturer Name: Boehringer Ingelheim
Manufacturer address line 1: Binger Strasse 173
Manufacturer address line 2:
Manufacturer's City: 6507 Ingelheim, Frankfurt
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62OAP09
Importers product description: 866434056340 MICARDIS 40MG
Refusal date: 03-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: 112-4141252-0/5/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3007025599
Manufacturer Name: Dima Diagnostika Gmbh
Manufacturer address line 1: Robert Bosch Breite 23
Manufacturer address line 2:
Manufacturer's City: Gottingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 88N--TR
Importers product description: 864258630210 DIAGNOSTIC TEST KITS
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3901953-5/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006175698
Manufacturer Name: Invivo Germany Gmbh
Manufacturer address line 1: Haus3
Manufacturer address line 2:
Manufacturer's City: Schwerin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76K--LE
Importers product description: Tumor localizer "LeLoc" device, unknown product code
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3905754-3/1/3/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006175698
Manufacturer Name: Invivo Germany Gmbh
Manufacturer address line 1: Haus3
Manufacturer address line 2:
Manufacturer's City: Schwerin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 78K--NW
Importers product description: 792090622000 NEEDLE
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3905754-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3006175698
Manufacturer Name: Invivo Germany Gmbh
Manufacturer address line 1: Haus3
Manufacturer address line 2:
Manufacturer's City: Schwerin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76K--LE
Importers product description: Tumor localizer "LeLoc" device, unknown product code
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3905754-3/1/2/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3004204361
Manufacturer Name: Bayer Ag
Manufacturer address line 1: Wd-isd/lev Postbuero K 17
Manufacturer address line 2:
Manufacturer's City: Leverkusen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 60RCE99
Importers product description: 865809822461 clobenzorex HCl
Refusal date: 03-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3884338-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006592922
Manufacturer Name: Telatec-Laser Gmbh
Manufacturer address line 1: Landauer Strasse 117
Manufacturer address line 2:
Manufacturer's City: Plattling
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 84L--LP
Importers product description: THERAPY LASER FOR PHYSIOTHERAPY-PERSONAL USE
Refusal date: 04-SEP-2008
FDA_District: PHI-DO
Entry/doc/line/sfx: UPS-2140390-0/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
NOT LISTED
REGISTERED
NO 510(K)
Manufacturer FEI: 3004862691
Manufacturer Name: Ahaus Gmbh
Manufacturer address line 1: Soegeler Street 3
Manufacturer address line 2:
Manufacturer's City: Hueven
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 03AGT99
Importers product description: Hummlinger Spelt Bread
Refusal date: 05-SEP-2008
FDA_District: NWE-DO
Entry/doc/line/sfx: 551-7190533-9/2/1/
Carrier:
Bill of Lading: GTMD00143521
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LACKS FIRM
ALLERGEN
Manufacturer FEI: 3007062913
Manufacturer Name: Di Budwig Gmbh & Co Kg
Manufacturer address line 1: Theaterwall 24
Manufacturer address line 2:
Manufacturer's City: Oldenburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VDA99
Importers product description: 963505455193 Eldi Oil (Linum Usitissimum, Triticum Vulgare)
Refusal date: 05-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-3920430-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
UNAPPROVED
NO ENGLISH
Manufacturer FEI: 1000279866
Manufacturer Name: Faber-Castell Gmbh
Manufacturer address line 1: Nuernberger Strasse
Manufacturer address line 2:
Manufacturer's City: Stein
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53CG-02
Importers product description: SEL-06 LEAF/SEL-09 Lagoon/SEL-08 Powder
Refusal date: 08-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: WIG-2045932-5/1/1/B
Carrier: MARTINAIR HOLLAND N.V.
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): UNSAFE COL
Manufacturer FEI: 3005942852
Manufacturer Name: Steierl-Pharma GmbH
Manufacturer address line 1: Postfach 12 68
Manufacturer address line 2: D-82207
Manufacturer's City: Herrsching
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: (Phytocortal) liquid medicines in glass bottles
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/B
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO ENGLISH
Manufacturer FEI: 3005946640
Manufacturer Name: Orthomed GmbH & Co. KG
Manufacturer address line 1: Herzogstrabe 30
Manufacturer address line 2:
Manufacturer's City: 40764 Lagenfeld
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Paks of powder type medicines(Ortho Molar Probiot), various
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/D
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO ENGLISH
Manufacturer FEI: 3005946701
Manufacturer Name: Arzneimittel
Manufacturer address line 1: KrauB D10
Manufacturer address line 2:
Manufacturer's City: 76275 Ettlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Various Pellet type medicines(Allium, Avena, Solidago) in gl
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/E
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LACKS N/C
Manufacturer FEI: 3005946832
Manufacturer Name: ASTA Medica AG
Manufacturer address line 1: WeismullerstraBe 45
Manufacturer address line 2:
Manufacturer's City: 60314 Frankfurt
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Apparent liquid medicine (Kamillosan Konzentrat) in glass bo
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/H
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LACKS N/C
NO ENGLISH
Manufacturer FEI: 3005946971
Manufacturer Name: ISO - Arzneimittel
Manufacturer address line 1: BunsenstraBe 6 - 10
Manufacturer address line 2:
Manufacturer's City: 76275 Ettlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Apparent liquid medicine (Umckaloabo) in glass
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/K
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LACKS N/C
NO ENGLISH
Manufacturer FEI: 3005948630
Manufacturer Name: Dr. Gustav Klein
Manufacturer address line 1: Postfach 1165
Manufacturer address line 2:
Manufacturer's City: 77732 Zell Am Harmersbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Apparent medicine (Prostamed & Uro-Select tablets) in plasti
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/M
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LACKS N/C
NO ENGLISH
Manufacturer FEI: 3005948690
Manufacturer Name: Coradol Pharma Gmbh
Manufacturer address line 1: Unknown address
Manufacturer address line 2:
Manufacturer's City: 50933 Koln
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Apparent liquid medicine (Coradol) in glass bottles
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/N
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LACKS N/C
NO ENGLISH
Manufacturer FEI: 3004200405
Manufacturer Name: Verla Pharm
Manufacturer address line 1: Bernriederstr 1
Manufacturer address line 2:
Manufacturer's City: Tutzing
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VCY99
Importers product description: Apparent patent medicines in paper/plastic containers
Refusal date: 09-SEP-2008
FDA_District: ATL-DO
Entry/doc/line/sfx: XXX-0149189-4/1/1/O
Carrier:
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
LABELING
Manufacturer FEI: 3002808472
Manufacturer Name: Waldemar Link GmbH & Co. KG (Corp. Hq.)
Manufacturer address line 1: Barkausenweg 10
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 87H--SN
Importers product description: ANKLES
Refusal date: 10-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: 008-0303332-3/2/1/
Carrier: SINGAPORE AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO PMA
Manufacturer FEI: 3004433220
Manufacturer Name: Glaxosmithkline Gmbh & Co
Manufacturer address line 1: Leopoldstrasse 175
Manufacturer address line 2:
Manufacturer's City: Munich
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62LDB44
Importers product description: 610148807549 Malarone
Refusal date: 10-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4076699-1/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3006773453
Manufacturer Name: Sybron Implant Solutions Gmbh
Manufacturer address line 1: Julius Bamberger Str 8a
Manufacturer address line 2:
Manufacturer's City: Bremen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76D--YJ
Importers product description: 791118094366/ORTHODONTIC SCREWS
Refusal date: 10-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4034006-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3004010466
Manufacturer Name: Essex Pharma
Manufacturer address line 1: 27
Manufacturer address line 2:
Manufacturer's City: Munich
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66VIP99
Importers product description: 861302495679 DOTRATURE 10MG
Refusal date: 11-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4059596-0/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53ED-01
Importers product description: Conditioner Avocado / mango
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/8/1/B
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53ED-01
Importers product description: Avacado / mango
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/8/1/C
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53ED-06
Importers product description: Shampoo Olive / Almond
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/8/1/D
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53ED-01
Importers product description: Conditioner Olive / Almond
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/8/1/E
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
Manufacturer FEI: 3001617395
Manufacturer Name: M Kappus Gmbh & Co
Manufacturer address line 1: Luisenstr 42 52
Manufacturer address line 2:
Manufacturer's City: Offenbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53JY-01
Importers product description: Honey Glycerine Soap 3 pack
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/3/1/B
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): UNSAFE COL
COSMETLBLG
Manufacturer FEI: 3001617395
Manufacturer Name: M Kappus Gmbh & Co
Manufacturer address line 1: Luisenstr 42 52
Manufacturer address line 2:
Manufacturer's City: Offenbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53JY-01
Importers product description: Aloe Vera Glycerine Soap 3 pack
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/3/1/C
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: Yes
FDA record of private lab sample analysis: No
Charge(s): UNSAFE COL
COSMETLBLG
Manufacturer FEI: 3001617395
Manufacturer Name: M Kappus Gmbh & Co
Manufacturer address line 1: Luisenstr 42 52
Manufacturer address line 2:
Manufacturer's City: Offenbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53JY-01
Importers product description: Lilly of the Valley bar soap
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/3/1/E
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNSAFE COL
COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53BD-99
Importers product description: Dulgon Sunny Lemon
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/6/1/B
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53ED-06
Importers product description: Shampoo avocado / mango
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/8/1/A
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53JI-02
Importers product description: Men high performance roll on deodorant
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/11/1/
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53BD-99
Importers product description: BATH PREPS
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/14/1/
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53BD-99
Importers product description: Shower Cream Olive Extract
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/15/1/A
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): COSMETLBLG
Manufacturer FEI: 3003962044
Manufacturer Name: Mann & Schroder
Manufacturer address line 1: Unknown Street
Manufacturer address line 2:
Manufacturer's City: Siegelsbach
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 53BD-99
Importers product description: Dulgan Men High Performance shower gel
Refusal date: 12-SEP-2008
FDA_District: NYK-DO
Entry/doc/line/sfx: D03-0171591-4/15/1/B
Carrier: AXEL KRAFT INTERNATIONAL LTD
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LABELING
COSMETLBLG
Manufacturer FEI: 3004582654
Manufacturer Name: Berlin Heart Ag
Manufacturer address line 1: Wiesenweg 10
Manufacturer address line 2:
Manufacturer's City: Berlin
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 74D--SQ
Importers product description: STATIONARY DRIVING UNITS
Refusal date: 12-SEP-2008
FDA_District: CHI-DO
Entry/doc/line/sfx: 112-3176213-2/1/1/
Carrier: LUFTHANSA CARGO AG
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): INVDEVICE
Manufacturer FEI: 3003199814
Manufacturer Name: Engelhard Arzneimittel
Manufacturer address line 1: 3 Herzbergstrasse
Manufacturer address line 2:
Manufacturer's City: Niederdorfelden
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 61WBO18
Importers product description: 863228352353 Mykoderm Cream
Refusal date: 19-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4140891-6/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3001743571
Manufacturer Name: Heel Gmbh
Manufacturer address line 1: Reckeweg Street 24
Manufacturer address line 2:
Manufacturer's City: Baden-Baden
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 66YAS99
Importers product description: 791124860300 Cerium Oxalicum & Manganum Phosphoricum
Refusal date: 19-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4217797-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
NOT LISTED
Manufacturer FEI: 3004535542
Manufacturer Name: Schnuchel
Manufacturer address line 1: Achter De Hoef 8
Manufacturer address line 2:
Manufacturer's City: Hetlingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 86H--QZ
Importers product description: 963098507658/FRAMES
Refusal date: 19-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4349856-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62OAB22
Importers product description: CARVEDILOL TABLETS 6.25MG FOR EXPORT ONLY "PLEASE REFUSE CAR
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/1/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62OAB22
Importers product description: CARVEDILOL TABLETS 12.5MG FOR EXPORT ONLY "PLEASE REFUSE CAR
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/2/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 61FAB56
Importers product description: CLARITHROMICIN 500MG FOR EXPORT ONLY, PLEASE REFUSE MERCHAND
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/3/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 61HAB43
Importers product description: LEVOFLOXACIN 500MG FOR EXPORT ONLY "PLEASE REFUSE CARGO"
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/4/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 62GDL18
Importers product description: DICLOFENAC SODIUM 50MG "FOR EXPORT ONLY" PLEASE REFUSE MERCH
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/5/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3004850451
Manufacturer Name: Wendt-Chemie Vertriebsges Mbh & Co.
Manufacturer address line 1: Wandsbeker Allee 72
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 61FAE53
Importers product description: CEFADROXIL MONOHYDRATE FOR EXPORT ONLY (PLEASE REFUSE MERCHA
Refusal date: 22-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: M21-0738332-7/6/1/
Carrier: MAERSK SEALAND
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNAPPROVED
Manufacturer FEI: 3003920566
Manufacturer Name: JOTEC Gmbh
Manufacturer address line 1: Lotzenacker 23
Manufacturer address line 2:
Manufacturer's City: Hechingen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 74D--SY
Importers product description: 862769559155 STENTS
Refusal date: 22-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-4119956-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): DIRECTIONS
REGISTERED
NO 510(K)
Manufacturer FEI: 3004093482
Manufacturer Name: Biotest Ag
Manufacturer address line 1: Siemensstr 11
Manufacturer address line 2:
Manufacturer's City: Dreieich
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 81M--WN
Importers product description: 859043804048 REAGENTS
Refusal date: 23-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-1438780-8/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 1000403564
Manufacturer Name: The Park Lane Confectionery Manufac
Manufacturer address line 1: Georgswerder Damm 12
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 33EGT05
Importers product description: 841945281755 CANDY
Refusal date: 23-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2440171-4/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): LIST INGRE
LACKS FIRM
NUTRIT LBL
Manufacturer FEI: 5833
Manufacturer Name: Eppendorf Geratebau Netheler + Hinz Gmbh
Manufacturer address line 1: Barkhausenweg 1
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 80L--DQ
Importers product description: LAB EQ FDA WE NEED REFUSAL NOTICE A.S.A.P. CARGO IS FOR EXPO
Refusal date: 24-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: EQ6-0008237-2/1/1/
Carrier: MARTINAIR HOLLAND N.V.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 5833
Manufacturer Name: Eppendorf Geratebau Netheler + Hinz Gmbh
Manufacturer address line 1: Barkhausenweg 1
Manufacturer address line 2:
Manufacturer's City: Hamburg
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 80L--DQ
Importers product description: LAB EQ FDA WE NEED REFUSAL NOTICE A.S.A.P. CARGO IS FOR EXPO
Refusal date: 24-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: EQ6-0008236-4/1/1/
Carrier: MARTINAIR HOLLAND N.V.
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: K-FILES, CC+, STERILE
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: FLEXICUT-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: HEDSTROEM-FILESM CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: GATES-ENLARGERS, C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/4/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: M2 BASIC SEQ, 4X,
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/1/5/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: HEDSTROEM-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: GATES-ENLARGE C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: PEESO-ENLARGERS C.A.
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: K-FILES, CC+
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/2/4/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL 2 IN 1 KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL DOWN PACK KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/2/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: BEEFILL KIT
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/3/3/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3002869944
Manufacturer Name: VDW Gmbh
Manufacturer address line 1: Bayerwaldstr 15
Manufacturer address line 2:
Manufacturer's City: Munchen
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 76E--MR
Importers product description: C-PILOT FILES, CC+ STERILE
Refusal date: 25-SEP-2008
FDA_District: FLA-DO
Entry/doc/line/sfx: AM1-0155000-3/4/1/
Carrier: SWISS INTERNTL AIRLINES
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): REGISTERED
Manufacturer FEI: 3006800417
Manufacturer Name: Ernst Engbring Gmbh
Manufacturer address line 1: Industriestr. 9
Manufacturer address line 2:
Manufacturer's City: Oer-Erkenschwick
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 77K--HL
Importers product description: 904024869962.HEARING AID
Refusal date: 26-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2581251-3/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NOT LISTED
NO 510(K)
Manufacturer FEI: 3005364311
Manufacturer Name: Rudolf Wild GmbH & Co. KG
Manufacturer address line 1: Rudolf-Wild-Strasse 107-115
Manufacturer address line 2:
Manufacturer's City: Heidelberg
Manufacturer Province/state: DE-NOTA
Manufacturer Country: Germany
Product code: 34FFT02
Importers product description: 942780499806 CHOCOLATE
Refusal date: 29-SEP-2008
FDA_District: NOL-DO
Entry/doc/line/sfx: 112-2314326-7/1/1/
Carrier: FEDERAL EXPRESS
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): UNSAFE COL
Manufacturer FEI: 3007111125
Manufacturer Name: Zuckersucht Gmbh
Manufacturer address line 1: Joseph-Dollinger-Bogen 22
Manufacturer address line 2:
Manufacturer's City: Munich
Manufacturer Province/state:
Manufacturer Country: Germany
Product code: 03AGE99
Importers product description: 100X GINGER BREADS/WESTIN/SAN ANTONIO, TX
Refusal date: 30-SEP-2008
FDA_District: CIN-DO
Entry/doc/line/sfx: UPS-2337059-4/1/1/
Carrier: UNITED PARCEL SERVICE
Bill of Lading:
FDA sample analysis: No
FDA record of private lab sample analysis: No
Charge(s): NO ENGLISH