Refusal Actions by FDA as Recorded in OASIS


   Country of Origin                     Entry #   DOC  Line Suffix
   Manufacture Name
   City / Country or region                                 District
   Product Code        Product Description
                          Date                              Reason
United Kingdom 110-0707733-8 1 5 Pharmacy2u Leedsleeds , GB LS14 1PQ PHI-DO 53BH-01 DEAD SEA SPA BATH SALTS PERSONAL USE DORIS JOHNSON 28-NOV-2007 HEALTH C Germany 112-8853665-1 4 1 Long Time Liner Zurich , DE NOL-DO 53CD-02 859020952291 LTL PENCIL 07-NOV-2007 UNSAFE COL CSTIC LBLG France 112-8795759-3 1 1 Orgev Laboratoires Rambouillet , FR 78120 NOL-DO 53CD-04 862506876384 Eyes Lift Serum 07-NOV-2007 CSTIC LBLG Germany 112-8853665-1 1 1 Long Time Liner Zurich , DE NOL-DO 53CD-07 859020952291 EYEBROW COLOUR 07-NOV-2007 UNSAFE COL CSTIC LBLG United Kingdom 112-8300445-7 5 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYESHADOW 13-NOV-2007 POISONOUS United Kingdom 112-8300445-7 5 2 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYESHADOW 13-NOV-2007 POISONOUS Taiwan 112-8894219-8 1 1 Cosmetics Tech Co., Kaohsiung , TW CHI-DO 53CH-03 PARADISE GREENS 19-NOV-2007 COSM COLOR Taiwan 112-8894219-8 2 1 Cosmetics Tech Co., Kaohsiung , TW CHI-DO 53CH-03 WATER COLORS 19-NOV-2007 COSM COLOR Taiwan 112-8894219-8 3 1 Cosmetics Tech Co., Kaohsiung , TW CHI-DO 53CH-03 NEUTRAL TONES 19-NOV-2007 COSM COLOR Pakistan K74-0141656-8 38 1 Kzk Industrial & Commercial Co. Karachi , PK CHI-DO 53CK-02 EYE LINER (KAJAL) TRADITIONAL EYE-LINER(PEN 13-NOV-2007 COSM COLOR India WUG-0123852-5 8 1 Gayatri Masala Exporter Nadiad IN-GJ, IN 387001 LOS-DO 53CY-02 KAJAL 05-NOV-2007 COSM COLOR Dominican Republic 516-2033570-6 1 1 Laboratorios Key C Por A Santo Domingo , DO NYK-DO 53ED-01 HAIR CONDITIONERS 29-NOV-2007 UNSAFE COL Dominican Republic 516-2033570-6 3 1 Laboratorios Key C Por A Santo Domingo , DO NYK-DO 53ED-06 SHAMPOOS 29-NOV-2007 UNSAFE COL Dominican Republic 516-2033570-6 2 1 Laboratorios Key C Por A Santo Domingo , DO NYK-DO 53EY-99 HAIR PREPARATIONS 29-NOV-2007 UNSAFE COL Germany 112-8853665-1 2 1 Long Time Liner Zurich , DE NOL-DO 53GD-05 859020952295 LIP COLOUR 07-NOV-2007 UNSAFE COL CSTIC LBLG Germany 112-8853665-1 4 2 Long Time Liner Zurich , DE NOL-DO 53GD-05 859020952291 LIP COLOUR 07-NOV-2007 UNSAFE COL CSTIC LBLG China ACN-1059800-9 2 2 Yangzhou Youchuanhao Tourist Produc Hangji Yangchuan City , CN LOS-DO 53IC-01 UNFLOURINATED TOOTHPASTE, SGS TEST CERTIFIED/NO DIETHYLENE G 30-NOV-2007 POISONOUS Thailand XXX-0152485-0 1 1 A Helpcare Enterprise Penang , MY NYK-DO 53ID-01 Toothpaste with Floride Fresh Stripe Gel 13-NOV-2007 NOT LISTED DIRECTIONS Thailand XXX-0152485-0 1 1 B Helpcare Enterprise Penang , MY NYK-DO 53ID-01 Toothpaste with Floride Clean Mint Paste 13-NOV-2007 NOT LISTED UNAPPROVED Thailand XXX-0152485-0 1 1 C Helpcare Enterprise Penang , MY NYK-DO 53ID-01 Toothpaste with Floride Icy Cool Mint Paste 13-NOV-2007 NOT LISTED UNAPPROVED Hong Kong SAR 700-0116566-4 4 1 Product Plus Ltd Kowloon , HK LOS-DO 53IG-01 FIRST CLASS AMENITY KITS, TOOTHPASTE 14-NOV-2007 NOT LISTED REGISTERED UNAPPROVED Hong Kong SAR 700-0116566-4 13 1 Product Plus Ltd Kowloon , HK LOS-DO 53IG-01 BUSINESS CLASS AMENITY KITS, TOOTHPASTE 14-NOV-2007 NOT LISTED REGISTERED UNAPPROVED Korea, Republic Of (South) WRE-0353975-6 6 1 DongSung Pharm.Co.,Ltd Seoul KR-NOTA, KR 132-853 LOS-DO 53IG-01 NANO TOOTHPASTE 15-NOV-2007 UNAPPROVED Korea, Republic Of (South) WRE-0353975-6 6 2 DongSung Pharm.Co.,Ltd Seoul KR-NOTA, KR 132-853 LOS-DO 53IG-01 INDAN TOOTHPASTE 15-NOV-2007 UNAPPROVED India WUG-0139181-1 16 1 J. D. Corporation Mumbai , IN LOS-DO 53IG-01 Toothpaste Babool (Natural strength for teeth) 28-NOV-2007 NOT LISTED China M94-0047527-0 2 1 Yangzhou Maple Imp&Exp Corp Yangzhou , CN FLA-DO 53JI-02 DEODORANT 01-NOV-2007 LABELING Netherlands Antilles JF7-0059227-8 1 1 Elko Org. Ltd. San Viltore , CH FLA-DO 53LC-01 CREAM MOISTURIZER 14-NOV-2007 UNAPPROVED Germany 112-8741218-5 1 1 B Vitalize Health Products Ltd Surbiton GB-SRY, GB KT58LQ NOL-DO 53LC-03 857073611011 Revitalizing Treatment and Night Cream 05-NOV-2007 COSM COLOR United States 946-0600587-7 1 3 Spectrum Cosmetics Commerce, CA 90040-3216 LOS-DO 53LC-06 MOISTURIZING (SKIN CARE PREPARATIONS);CREAM; 14-NOV-2007 NOT LISTED United Kingdom MA7-0629415-8 10 1 B Steiner Transocean Ltd Middx , GB HA36BZ FLA-DO 53LD-06 Anti wrinkle gel 13-NOV-2007 COSMETLBLG India 112-6774122-3 1 1 A Target Logistiics Vijayawada , IN 520001 NOL-DO 53LD-99 Cosmetics 14-NOV-2007 COSMETLBLG Japan EE6-1339917-3 4 1 Leo D'Or Trading Co Ltd Tokyo , JP 103 ATL-DO 53LF-01 HERBAL WRAP/PAD FOR SKIN CARE/CLEANSING 30-NOV-2007 UNAPPROVED Spain WJD-0027503-0 1 3 L Bio-Col S.L. Barcelona , ES FLA-DO 53LY-01 Cleansing Gel w/Oats 15-NOV-2007 UNSAFE COL United Kingdom MA7-0629415-8 15 1 Steiner Transocean Ltd Middx , GB HA36BZ FLA-DO 53MC-01 TANNING LOTION 13-NOV-2007 COSMETLBLG Poland 322-3362825-7 1 1 Pphu Aroma Trend Piotr Draniak Michalowice , PL 05-816 LOS-DO 53MD-02 MASA COOLING BRONZER 14-NOV-2007 DIRECTIONS COSMETIC LACKS FIRM LACKS N/C Poland 322-3362825-7 2 1 Pphu Aroma Trend Piotr Draniak Michalowice , PL 05-816 LOS-DO 53MD-02 MASA TRIPLE BRONZER 14-NOV-2007 DIRECTIONS COSMETIC LACKS N/C LACKS FIRM Colombia 112-8874726-6 9 1 Laboratorios Dermanat S.A. Cali , CO NOL-DO 53RC-12 862765706769 COSMETIC SKIN CARE 07-NOV-2007 CSTIC LBLG