Refusal Actions by FDA as Recorded in OASIS for Germany
Manufacture Name
City / Country or region District Entry/Doc/Line/Suffix
Product Code Product Description
Date Reason
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/7/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/18/3
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/27/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/27/2
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/40/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/46/1
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/53/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/53/2
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/60/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/60/3
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/66/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/66/3
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/75/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/75/2
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/83/1
53CC-02 EARTH EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Schwan Cosmetics Gmbh & Co. KG
Heroldsberg , DE 90562 SWI-DO 231-7408047-6/83/2
53CC-02 GUNMETAL EYELINER
02-JAN-2008 COSM COLOR
CSTIC LBLG
Mann Schroder Gmbh
Baden , DE NYK-DO D03-0151489-5/6/1B
62GDL99 Psoriasis cream
03-JAN-2008 NOT LISTED
Mann Schroder Gmbh
Baden , DE NYK-DO D03-0151489-5/8/1
62SML99 Dandruff shampoo
03-JAN-2008 NOT LISTED
W Schumacher & Co Gmbh
Wittlich , DE 54516 CHI-DO 337-0089806-8/1/1
24UGH11 DEHYDRATED CELERY STALK & LEAF
07-JAN-2008 PESTICIDES
W Schumacher & Co Gmbh
Wittlich , DE 54516 CHI-DO 337-0089806-8/1/2
24UGH11 DEHYDRATED CELERY STALK & LEAF
07-JAN-2008 PESTICIDES
Lebkuchen-Schmidt Gmbh
Nurnberg , DE 90469 NOL-DO 112-5776887-1/8/1
03RGE99 909291699920 CHOCOLATE NUTS
09-JAN-2008 UNSAFE COL
Scanditronix Wellhofer Dosimetry
Schwarzenbruck , DE 90592 CHI-DO BQR-0000039-0/1/1
90I--ZH PASMAM DIGITA MAMOGRAPHIC EQUIPMENT
09-JAN-2008 NO 510(K)
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/2
53LD-99 861149906309 SKIN SERUM
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/3
53LD-06 861149906309 MOISTURIZING GEL
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/4
53LD-06 861149906309 MOISTURIZING GEL
09-JAN-2008 COSM COLOR
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/5
53LD-10 861149906309 MENULPHIA HYDRATANTE
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/6
53LD-10 861149906309 MENULPHIA CREAM
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/8
53LD-01 861149906309 CLEANSING MILK
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/9
53LD-06 861149906309 VISALIX HYDROSTABILE
09-JAN-2008 COSM COLOR
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/10
53LD-01 861149906309 CLEANSING GEL
09-JAN-2008 CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/13
53LD-08 861149906309 MUDD FACE MASK
09-JAN-2008 COSMETLBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/14
53LD-06 861149906309 BEAUTY CREAM
09-JAN-2008 COSM COLOR
CSTIC LBLG
Labothene
Pforzeheim Allemagne , DE D-75179 NOL-DO 112-7501645-1/1/15
53LD-06 861149906309 BEAUTY CREAM
09-JAN-2008 COSM COLOR
CSTIC LBLG
Scanditronix Wellhofer Dosimetry
Schwarzenbruck , DE 90592 CHI-DO BQR-0000039-0/2/1
90I--ZH CDMAM CONTRAST-DETAIL PHANTOM FOR MAMMOGRAPHY
10-JAN-2008 NOT LISTED
NON STD
Scanditronix Wellhofer Dosimetry
Schwarzenbruck , DE 90592 CHI-DO BQR-0000039-0/30/1
90I--XF KERMAX-SYSTEMS
10-JAN-2008 NOT LISTED
NON STD
Scanditronix Wellhofer Dosimetry
Schwarzenbruck , DE 90592 CHI-DO BQR-0000039-0/3/1
95L--22 PHOTOMETER
10-JAN-2008 NON STD
NO REGISTR
Tetra Pak Ab
Lund , SE S 221 86 CHI-DO 916-1659258-9/148/1
95L--22 "LASER SENSOR, FR20RL"
10-JAN-2008 FAILS STD
NON STD
Boening F
Finek , DE SAN-DO 112-0567530-2/1/1
66VBV99 861607398973 MEDICINE
10-JAN-2008 UNAPPROVED
GE OEC Medical Systems Gmbh
Wendelstein , DE D-90530 NOL-DO 112-7602375-3/1/1
90I--ZO 856622330680 XRAY GENERATOR
13-JAN-2008 FAILS STD
Boehringer Ingelheim
6507 Ingelheim, Frankfurt , DE D 6507 BLT-DO 336-7498885-5/1/1
61LDS05 ATROPINE SULFATE
14-JAN-2008 DIRECTIONS
Boehringer Ingelheim
6507 Ingelheim, Frankfurt , DE D 6507 BLT-DO 336-7497742-9/1/1
61LDS05 ATROPINE SULFATE
Partial Refusal 14-JAN-2008 DIRECTIONS
Labor Bio
Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 110-1051528-2/1/4
66PBL99 Facial Oil
18-JAN-2008 DIRECTIONS
Labor Bio
Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 110-1051528-2/1/1
53MD-02 Tanning Oil Spray
18-JAN-2008 DIRECTIONS
Labor Bio
Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 110-1051528-2/1/2
53MD-02 Sunblock Gel
18-JAN-2008 DIRECTIONS
Labor Bio
Guelichstrasseguelichstrasse , DE P-75179 NYK-DO 110-1051528-2/1/3
53MC-02 Sunblock Cream
18-JAN-2008 DIRECTIONS
Eppendorf Geratebau Netheler + Hinz Gmbh
Hamburg , DE 22339 FLA-DO EQ6-0007111-0/1/1
80L--DQ LAB EQ FDA PLS ISSUE REFUSAL NOTICE IMMEDIATELY FOR EXPORT O
18-JAN-2008 NOT LISTED
REGISTERED
Labiosthetique
Pforzheimpforzheim , DE NYK-DO 110-1285805-2/1/6
66PBJ99 Sunblock Cream (SPF 15)
25-JAN-2008 NOT LISTED
DIRECTIONS
Pascoe Gmbh
Gie?en , DE 35394 SAN-DO 112-0814866-1/1/1
62GAY99 862565875880 LYMPHDIARAL DRAINAGE CREAM
25-JAN-2008 NOT LISTED
Sanum Kehlbeck Gmbh & Co Kg
Hoya , DE 27316 SAN-DO 112-0814866-1/1/2
62KAK99 862565875880 HOMEOPATHIC DROPS
25-JAN-2008 NOT LISTED
Biologishche Heilmittel
Baden , DE SAN-DO 112-0814866-1/1/3
62GAB99 862565875880 HOMEOPATHIC TABLETS
25-JAN-2008 NOT LISTED
Weleda AG
Schwabisch Gmund , DE 73525 NOL-DO 112-8100073-9/1/1
54AYY99 837407384245 DIETARY SUPP.
28-JAN-2008 NO ENGLISH