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
China M50-0003277-6 59 1 Taiyen Biotech Co Ltd Beiging , CN 1000020 NYK-DO 53BD-02 Good Clean Fun Bubbly Suds for Tub & Shower- Fish 01-AUG-2008 UNSAFE COL COSMETLBLG China ACN-3000097-8 1 1 Zhuhai Maxis Cosmetics Production Guangdong , CN CHI-DO 53CH-03 ULTA PRO BROW KIT - 2 EYEBROW COLORS & ONE HIGHLIGHTER 18-AUG-2008 POISONOUS HELD INSAN Taiwan 315-7684566-8 1 1 Vast Gem International Co Ltd Tainantainan , TW 70000 LOS-DO 53CH-03 EYESHADOW 27-AUG-2008 UNSAFE COL Germany 112-3713161-3 1 1 Schwan Cosmetics Gmbh & Co. KG Heroldsberg , DE 90562 NOL-DO 53CK-02 864296932391/COSMETIC LIPLINERS/.01OZ 06-AUG-2008 CSTIC LBLG COSMETLBLG China 113-4425088-8 1 1 Xin Gao Industry Co., Ltd Dongguang City , CN LOS-DO 53EA-02 HAIR GROWTH HERBAL SPRAY 60ML 3 BOTTLES/PACK 13-AUG-2008 NOT LISTED UNAPPROVED China 113-4425089-6 1 1 Xin Gao Industry Co., Ltd Dongguang City , CN LOS-DO 53EA-02 HAIR GROWTH HERBAL SPRAY 60ML 3 BOTTLES/PACK 13-AUG-2008 NOT LISTED UNAPPROVED Argentina 112-1417861-1 1 4 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53ED-99 863669897630 HAIR OIL 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG France 322-6278982-2 12 1 Pierre Fabre Dermo Cosmetique Castres Cedex , FR 81106 NOL-DO 53EY-06 SHAMPOO 13-AUG-2008 CSTIC LBLG India 411-8164487-7 4 1 A Pearls of Beauty Distt. Solan (H.P.) , IN SWI-DO 53FH-02 HEENA POWDER 18-AUG-2008 COSM COLOR India 411-8164487-7 4 1 B Progression India Pvt Ltd Solan-Shimla , IN 174103 SWI-DO 53FH-02 Napur Natural Mehendi (Heena) 18-AUG-2008 COSM COLOR Argentina 112-1417861-1 2 1 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53GC-05 863669897630 LIP CREAM 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG Canada 551-7661466-2 1 1 Demco Manufacturing Inc Saint-Hubert QC, CA J3Y2S3 NYK-DO 53GD-04 LEG AND BODY PAINTS (MAKEUP PREPARATIONS, NOT FOR EYES);LIQU 08-AUG-2008 COSM COLOR POISONOUS China UPS-2251091-4 1 1 Modern Consultants Ltd Shenzhen , CN SEA-DO 53GY-05 941218-COSMETIC SET 05-AUG-2008 COSM COLOR Korea, Republic Of (South) WO1-0175212-0 1 1 Ace Silver Plus Bucheon-Si, Gyeonggi-Do, Korea , KR LOS-DO 53IG-01 TOOTH PASTE 13-AUG-2008 NOT LISTED China 663-0835188-2 1 1 Fuzhou Difeng Bio-Tech Co., Ltd. Jinshan Industrial Area, Fuzhou , CN LOS-DO 53IK-99 DISPENSER PEN FOR TOOTH WHITENING 27-AUG-2008 DIRECTIONS LACKS FIRM LACKS N/C REGISTERED Korea, Republic Of (South) U47-0462404-6 55 1 SHINSEGAE DISTRIBUTION CO., LTD. BUK-GU KR-29, KR 500-828 ATL-DO 53JD-01 BAMBOO LIQUID 14-AUG-2008 NO ENGLISH Korea, Republic Of (South) WIB-1216227-0 4 1 Ajou Medics Co., Ltd Seoul , KR LOS-DO 53JD-01 DR. ESLEE HYGIENIC INNER CLEANSER 150ML (3BOX) 26-AUG-2008 NOT LISTED Brazil DP4-0439921-5 9 1 Quanto Mais Importamo and Exportamo LTDA Rio De Janeiro BR-RJ, BR 22451540 FLA-DO 53JL-01 SOAP BARS 14-AUG-2008 LABELING Korea, Republic Of (South) WIB-1215298-2 16 1 Hanbul Cosmetics Co., Ltd Seoul , KR LOS-DO 53LC-01 ICS INTENSIVE LEPORTS CREAM 20-AUG-2008 NOT LISTED Thailand 277-0119117-6 21 1 Cm Cosmetic Ltd. Khonkaen , TH LOS-DO 53LC-03 Triethanolamine w/ demelanizing cream 13-AUG-2008 NOT LISTED UNAPPROVED India 429-0772409-2 1 1 D Abdallah Omar Ahmed Jeddah , SA SEA-DO 53LC-03 Fair & Lovely multiVitamin TOTAL FAIRNESS CREAM 18-AUG-2008 UNAPPROVED India 429-0772421-7 7 1 C Ayman Said Bdallah Jeddah , SA SEA-DO 53LC-03 Fair & Lovely multiVitamin TOTAL FAIRNESS CREAM 18-AUG-2008 NOT LISTED UNAPPROVED Argentina 112-1417861-1 1 1 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53LC-03 863669897630 BLEACHING CREAM 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG Argentina 112-1417861-1 1 5 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53LC-03 863669897630 IDEBENONA CREAM 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG Argentina 112-1417861-1 1 2 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53LC-03 863669897630 ARGIRLENE CREAM 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG Korea, Republic Of (South) WIB-1212918-8 21 1 Hanbul Cosmetics Co. Seoul , KR LOS-DO 53LC-07 PERFECT SOLUTION AW CREAM 06-AUG-2008 UNAPPROVED Jamaica HH7-0281160-0 7 1 Geddes Grant T (Distbrs) Ltd Kingston 11 , JM FLA-DO 53LC-99 LANDERS VANISHING CREAM 11-AUG-2008 CSTIC LBLG Jamaica HH7-0281160-0 7 2 E W Abrahams Son Kingston 10 , JM FLA-DO 53LC-99 NADINOLA BEAUTY CREAM 11-AUG-2008 CSTIC LBLG Hong Kong SAR UPS-1880358-3 1 1 Jenny Beauty College Kowloonkowloon , HK 999999 NYK-DO 53LC-99 MOLE REMOVAL CREAM 19-AUG-2008 NOT LISTED Venezuela 112-1622868-7 1 3 Inversiones Rodven Caracas , VE NOL-DO 53LC-99 860786271489 STRIDERM 22-AUG-2008 CSTIC LBLG Venezuela 112-1622868-7 1 1 Inversiones Rodven Caracas , VE NOL-DO 53LC-99 body gel 22-AUG-2008 CSTIC LBLG COSMETLBLG Guyana N56-0015958-0 3 1 A Atlantic Pharmaceuticals Corp Georgetown , GY NYK-DO 53LD-01 Canadian Healing Oil 21-AUG-2008 LABELING Guyana N56-0015958-0 3 1 B Atlantic Pharmaceuticals Corp Georgetown , GY NYK-DO 53LD-01 Whitfield's Lotion 21-AUG-2008 LABELING United Arab Emirates WUG-0142407-5 9 1 Dabur International Limited Jebel Ali , AE LOS-DO 53LD-03 LAL TAIL 13-AUG-2008 UNAPPROVED Argentina 112-1417861-1 1 3 Emma Lina Maggiore Vte Lopez , AR 1638 NOL-DO 53LD-03 863669897630 ARNICA GEL FOR BRUISING 21-AUG-2008 CSTIC LBLG LABELING COSMETLBLG India AYG-1001416-0 28 1 P.S. Exporters Agency Punjab , IN SAN-DO 53LD-06 NYCIL POWDER 26-AUG-2008 UNAPPROVED Hungary ARM-0034875-1 11 1 Eminence Organic Skin Care Inc. Vancouver BC, CA V5Y3J6 SEA-DO 53LG-09 SEVEN HERB TREATMENT 19-AUG-2008 CSTIC LBLG Nigeria 512-1004989-9 35 1 Mentholatum Nigeria Limited Kona , NG SWI-DO 53LY-01 MENTHOLAUM BALM 05-AUG-2008 UNAPPROVED Nigeria 512-1004989-9 36 1 PZ Nigeria Limited Lagos Ng-La, NG None SWI-DO 53LY-01 HEATOL BALM 05-AUG-2008 UNAPPROVED Nigeria 512-1004989-9 37 1 PZ Cussons Industries (Ghana) Ltd. Tema , NG SWI-DO 53LY-01 ROBB BALM 05-AUG-2008 UNAPPROVED Korea, Republic Of (South) AEK-9533387-4 1 1 Eusung Global Corp Seoul , KR CIN-DO 53LY-99 SKIN CARE DEVICE 13-AUG-2008 NOT LISTED REGISTERED NO 510(K) Australia UPS-1807765-9 1 1 A Vani-T Pty Ltd Lonsdalelonsdale , AU 5160 CIN-DO 53MD-02 Liquid Sun MEDIUM 14-AUG-2008 COSM COLOR Australia UPS-1807765-9 1 1 B Vani-T Pty Ltd Lonsdalelonsdale , AU 5160 CIN-DO 53MD-02 Liquid Sun DARK 14-AUG-2008 COSM COLOR United Kingdom AFJ-0040187-2 52 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53SY-01 Antibacterial Soap 05-AUG-2008 CSTIC LBLG LABELING India 112-1761617-9 2 1 Himalaya Drug Co Priv Ltd Bangalore-2 , IN 562123 NOL-DO 53YC-02 FAIR & LOVELY 21-AUG-2008 LABELING Mexico BRQ-0032908-7 2 1 Internacional Heavenly De Mexico S De Rl De C.V Jalisco , MX 15000 SWI-DO 53YD-99 SUNSCREEN LOTION, METROPOLISUN 90 FPS 11-AUG-2008 FRNMFGREG INCONSPICU Mexico BRQ-0033420-2 1 3 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53YD-99 PONDS H MOISTURIZING CREAM W/ FILRO PROTECTOR 19-AUG-2008 CSTIC LBLG Mexico BRQ-0033420-2 1 4 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53YD-99 PONDs CLARANT B3 WITH FILTRO UV, 400 G 19-AUG-2008 UNAPPROVED Mexico BRQ-0033420-2 1 5 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53YD-99 PONDS CLARANT B3 WITH FILTRO UV, 200 G 19-AUG-2008 UNAPPROVED Mexico D01-0818650-9 1 1 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53YD-99 Clarant B3 Face Powder with sunscreen/ piel apinonada 19-AUG-2008 CSTIC LBLG Mexico D01-0818650-9 1 2 Unilever de Mexico S.A. de C.V. Cuernevaca, Morelos , MX 62500 SWI-DO 53YD-99 Clarant B3 Face Powder with sunscreen/ piel clara 19-AUG-2008 CSTIC LBLG Lebanon 112-1884082-8 6 1 Amana Care Sarl Beirut , LB NOL-DO 53YD-99 856017732715 COSMETIC 22-AUG-2008 CSTIC LBLG COSMETLBLG