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 112-1831044-2 2 1 Nougat London Ltd Enfieldenfield , GB EN03 NOL-DO 53BC-03 949511021369 CREAM BATH AND BATH PEARLS 04-APR-2008 COSM COLOR COLOR LBLG United Kingdom 112-1831012-9 1 2 Nougat London Ltd Enfieldenfield , GB EN03 NOL-DO 53BC-03 949511021667 CREAM BATH, SHOWER GEL, BODY SHIMMER 04-APR-2008 COSM COLOR COSMETLBLG United Kingdom 946-0605602-9 134 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX HERBAL LIQUID SOAP 6/500ML 01-APR-2008 LACKS N/C United Kingdom 946-0605602-9 244 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX HERBAL SOAP 01-APR-2008 LABELING United Kingdom 946-0605603-7 173 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX HERBAL LIQUID SOAP 500M 11-APR-2008 CSTIC LBLG United Kingdom 946-0605101-2 211 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX SLEEP EASY HERBAL BATH 19-APR-2008 NOT LISTED Taiwan 315-7682134-7 6 1 Vast Gem International Co Ltd Tainantainan , TW 70000 LOS-DO 53CH-03 EYESHADOW 19-APR-2008 UNSAFE COL Taiwan 880-1000104-3 2 1 Lian Co., Ltd. Tainan , TW LOS-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 22-APR-2008 UNSAFE COL United Kingdom 112-1846023-9 6 5 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYESHADOW 30-APR-2008 FILTH United Kingdom 112-1822370-2 2 6 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW 30-APR-2008 FILTH United Kingdom 112-1822370-2 2 8 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW 30-APR-2008 FILTH United Kingdom 112-1813798-5 8 7 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW 30-APR-2008 FILTH Taiwan 880-1000104-3 3 1 Lian Co., Ltd. Tainan , TW LOS-DO 53CK-01 EYEBROW PENCIL (EYE MAKEUP PREPARATIONS);STICKS; 22-APR-2008 UNSAFE COL India 300-1971166-0 17 1 Thakar Exports Trinagar-Delhi , IN 110035 CHI-DO 53DD-01 WOODVARD GRIP WATER 14-APR-2008 NOT LISTED UNAPPROVED France NL7-0104778-8 3 1 A Novafrica Bordeaux , FR 33000 FLA-DO 53ED-01 Hair Nourishing Care Treatment with Jojoba 28-APR-2008 COSM COLOR India UPS-0685639-1 23 1 Grandways New Delhi , IN 110025 SEA-DO 53FD-01 BEGIN HAIR COLOR with placeholders for quantity and value 22-APR-2008 CSTIC LBLG COSMETLBLG Canada 551-7355706-2 2 1 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT 01-APR-2008 POISONOUS Canada 551-7355706-2 2 2 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - YELLOW 01-APR-2008 POISONOUS Canada 551-7355706-2 2 3 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - ORANGE 01-APR-2008 POISONOUS Canada 551-7355706-2 2 4 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - RED 01-APR-2008 POISONOUS Canada 551-7355706-2 2 5 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - GREEN 01-APR-2008 POISONOUS Canada 551-7355706-2 2 6 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - BLUE 01-APR-2008 POISONOUS Canada 551-7355706-2 2 8 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - BLACK 01-APR-2008 POISONOUS Canada 551-7355706-2 2 7 Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 FACE PAINT - BROWN 01-APR-2008 POISONOUS Korea, Republic Of (South) ANP-0009485-5 18 1 Daiso Industries Co., Ltd. Higashihiroshima , JP 739-0008 SEA-DO 53ID-02 MOUTH MASH 22-APR-2008 CSTIC LBLG India 411-8162557-9 11 1 B Swastik Trading Co. Mumbai IN-MH, IN 400092 SWI-DO 53IY-02 CHANDAN Mouth Fresheners Tower Pack 25-APR-2008 COLOR LBLG China BGK-0611023-4 9 1 Jets Sets & Elephants Beauty Cor Montreal QC, CA H2P2T4 NYK-DO 53JD-01 SHOWER GEL 10-APR-2008 COSM COLOR Israel T94-0047924-0 19 1 Yakov Baron Kiryat Ono , IL 55226 FLA-DO 53JG-01 HAWAII SOAP BAR 15-APR-2008 CSTIC LBLG LABELING Mexico BVK-0025257-2 3 1 Colgate Palmolive SA de CV Mexico City , MX 11500 SWI-DO 53JG-01 PALMOLIVE BATH BAR SOAPS 17-APR-2008 COLOR LBLG CSTIC LBLG Australia 603-1080182-8 77 1 Reckitt Benckiser New South Whales , AU SEA-DO 53JI-02 REXONA DEOD ICE COOL 23-APR-2008 NOT LISTED Australia 603-1080182-8 85 1 Reckitt Benckiser New South Whales , AU SEA-DO 53JI-02 REDWIN/REXONA DEODRANT 23-APR-2008 NOT LISTED Chile W16-5013968-8 3 1 Laboratories Coesam La Reina , CL FLA-DO 53JY-01 UVATHERAPY SOAP BAR 03-APR-2008 COL ADDED Switzerland 112-1816663-8 1 1 A Dr Paul Et Kain Herzog Sa Lutry , CH 1095 NOL-DO 53LC-01 Karin Herzog Vitamin H 03-APR-2008 COSM COLOR COSMETLBLG United Kingdom 112-1831044-2 3 1 Nougat London Ltd Enfieldenfield , GB EN03 NOL-DO 53LC-03 949511021369 MY HANDS GIFT SET AND HAND CREAM 04-APR-2008 COSM COLOR COLOR LBLG United Kingdom 112-1831012-9 1 1 Nougat London Ltd Enfieldenfield , GB EN03 NOL-DO 53LC-03 949511021667 HAND CREAMS AND HAND POLISH 04-APR-2008 COSM COLOR COSMETLBLG Thailand 277-0116646-7 21 1 Cm Cosmetic Ltd. Khonkaen , TH LOS-DO 53LC-03 ARCHE PEARL CREAM 18-APR-2008 NOT LISTED United Kingdom 946-0605602-9 56 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL DISINFECTANT-LIQUID 12/9 OZ (250ML) 01-APR-2008 LABELING Lebanon 112-2025124-6 2 1 C Diana De Beaute s.a.l. Beirut , LB NOL-DO 53LC-99 963172497895 Diana ( Redness cream) 09-APR-2008 CSTIC LBLG United Kingdom 946-0605603-7 169 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL ANTISEPTIC LIQUID 500ML 11-APR-2008 CSTIC LBLG China BGK-0611023-4 8 1 Jets Sets & Elephants Beauty Cor Montreal QC, CA H2P2T4 NYK-DO 53LD-03 BODY LOTION 10-APR-2008 COSM COLOR France NL7-0104778-8 1 1 D Novafrica Bordeaux , FR 33000 FLA-DO 53LD-03 Serum Ultra White 28-APR-2008 CSTIC LBLG United Kingdom 112-1831044-2 1 1 Nougat London Ltd Enfieldenfield , GB EN03 NOL-DO 53LD-06 949511021369 DRY OIL MIST 04-APR-2008 COLOR LBLG China 220-1044396-2 1 2 American Hygienics Corporation Shanghai , CN 201702 LOS-DO 53LF-01 ITCH STOP WIPES 11-APR-2008 NEW VET DR Korea, Republic Of (South) 112-2349873-7 1 1 Natuzen Co Incheon , KR SEA-DO 53LY-01 8624-8228-4293 NWC21 Collagen Cellulose Mask, 500 pcs 30-APR-2008 CSTIC LBLG China AEK-9438323-5 1 1 Ab Hongkong Beauty & Health Ningbo , CN 315000 CIN-DO 53LY-99 PULSED LIGHT FOR SKIN CARE TREATMENT 03-APR-2008 NOT LISTED REGISTERED NO 510(K) Japan AJR-7266470-7 4 1 A Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO 53LY-99 3D-DEEP BOTOLIUM Transdermal Facial Gel for Visible Wrinkle 15-APR-2008 NO ENGLISH UNAPPROVED Japan AJR-7266470-7 4 1 B Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO 53LY-99 3D-DEEP BOTOLIUM Under-Eye Treatment Transdermal Under-Eye M 15-APR-2008 UNAPPROVED Japan AJR-7266470-7 6 1 Dr. Ci Labo Co Ltd Tokyo , JP LOS-DO 53LY-99 3D- Deep Botolium D-Trans-System Extra Deeper Formula 15-APR-2008 UNAPPROVED Korea, Republic Of (South) AEK-9436818-6 1 3 Caregen Co Ltd Gyeongi-Do , KR CIN-DO 53MC-99 ANTI AGING COSMETICS 03-APR-2008 NOT LISTED India K80-0941427-8 12 2 Varun Exports Ludhiana IN-PB, IN 141008 SAN-DO 53YG-99 HEHA MEHNDI BODY COLOR 15-APR-2008 COSM COLOR United States M76-9077049-1 1 1 A Tattoo Manufacturing, Inc. Tucson, AZ 85713-5343 DET-DO 53YY-99 Kids Rule Tattoos 14-APR-2008 CSTIC LBLG LABELING COSMETLBLG United States M76-9077049-1 1 1 B Tattoo Manufacturing, Inc. Tucson, AZ 85713-5343 DET-DO 53YY-99 WildFire Choppers Tattoos 14-APR-2008 CSTIC LBLG LABELING COSMETLBLG United States M76-9077049-1 1 1 C Tattoo Manufacturing, Inc. Tucson, AZ 85713-5343 DET-DO 53YY-99 Muscle Tattoo Sets 14-APR-2008 CSTIC LBLG LABELING COSMETLBLG United States M76-9077049-1 1 1 D Tattoo Manufacturing, Inc. Tucson, AZ 85713-5343 DET-DO 53YY-99 Colored Glitter Tattoos 14-APR-2008 CSTIC LBLG LABELING COSMETLBLG United States M76-9077049-1 1 1 E Tattoo Manufacturing, Inc. Tucson, AZ 85713-5343 DET-DO 53YY-99 Tattoo Mix 14-APR-2008 CSTIC LBLG LABELING COSMETLBLG China MY1-0339876-3 6 1 Gong Ming Tian Liao Wing Cheong Mfy Shenzhen , CN BLT-DO 53YY-99 TATTOOS 16-APR-2008 UNSAFE COL Estonia H42-0094009-0 1 1 A Wellspa Raplamaa , EE 78203 MIN-DO 53YY-99 Feng Shui Spa 2G machines - SG20801/2... 28-APR-2008 NO 510(K)