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 946-0600448-2 53 1 Sara Lee Household & Body Care Slough FN, GB LOS-DO 53BD-01 RADOX HERBAL LIQUID SOAP 500ML 27-SEP-2007 NOT LISTED Nigeria J50-0097872-4 2 1 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53BF-99 TETMESOL SOAP 13-SEP-2007 UNAPPROVED India 517-0172253-3 28 1 C Hasham Manji Padamshi Surmawalla Mumbai -3 , IN SWI-DO 53CH-02 1 carton of Khojati Surma No 13 (Not listed on commercial in 25-SEP-2007 COSM COLOR India 517-0172253-3 28 1 D Western India Chemical Co. Vasai Thane, IN 401208 SWI-DO 53CH-02 5 cartons of Jai Kajal (Not listed on commercial invoice) 25-SEP-2007 COSM COLOR United Kingdom T77-1022783-8 3 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 18-SEP-2007 POISONOUS United Kingdom T77-1022839-8 1 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 18-SEP-2007 POISONOUS United Kingdom T77-1023095-6 1 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 18-SEP-2007 CONTAINER United Kingdom T77-1020064-5 1 1 Coty Manufacturing UK Ltd. Ashford Kent, GB TN25 4AQ NYK-DO 53CH-03 EYE SHADOW (EYE MAKEUP PREPARATIONS);POWDER; 18-SEP-2007 POISONOUS HELD INSAN India 517-0172253-3 28 1 B Standard Pencils (P) Ltd. Chennai , IN 600032 SWI-DO 53CK-01 1 Carton of Lakme Eyebrow Pencil (Invoice page 8, item 133) 25-SEP-2007 LABELING COSMETLBLG India 517-0172253-3 28 1 A Aero Pharma (Silvassa) Silvassa , IN 396230 SWI-DO 53CK-02 1 Carton of Lakme Kajal Pencil (Invoice page 8, item 133) 25-SEP-2007 COSM COLOR Hong Kong SAR BXM-0000618-8 2 1 Suifan'S Imp & Exp Trading Co. Hong Kong , HK LOS-DO 53DD-02 SUIFAN'S KWANG TZE SOLUTION 16-SEP-2007 NOT LISTED UNAPPROVED Italy CDX-0042271-9 1 7 Pettenon Cosmetic Snc San Martino Di Lupari PD, IT 35018 SJN-DO 53EC-99 HAIR PREPARATION PRODUCTS 11-SEP-2007 UNAPPROVED India DY2-0707022-7 2 17 Hesh Herbal PVT LTD Mumbai IN-NOTA, IN none SWI-DO 53ED-01 "Hesh" Amla Herbal Hair Oil (200 ml) 21-SEP-2007 COSM COLOR India DY2-0707022-7 2 18 Hesh Herbal PVT LTD Mumbai IN-NOTA, IN none SWI-DO 53ED-01 "Hesh" Brahmi Amla Herbal Hair Oil (200 ml) 21-SEP-2007 COSM COLOR Canada 112-8006986-7 3 1 Salon Label Inc Victoria BC, CA V8Z1A6 NOL-DO 53ED-02 861539754533/HAIR SPRAY 14-SEP-2007 CSTIC LBLG COSMETLBLG COSMETLBLG Canada 112-8006986-7 3 2 Salon Label Inc Victoria BC, CA V8Z1A6 NOL-DO 53ED-02 861539754533/HAIR SPRAY 14-SEP-2007 CSTIC LBLG COSMETLBLG COSMETLBLG Canada 112-8006986-7 1 1 Salon Label Inc Victoria BC, CA V8Z1A6 NOL-DO 53ED-04 861539754533/HAIR TEXTURISER 14-SEP-2007 CSTIC LBLG COSMETLBLG COSMETLBLG Canada 112-8006986-7 2 1 Salon Label Inc Victoria BC, CA V8Z1A6 NOL-DO 53ED-99 861539754533/HAIR PREPARATIONS 14-SEP-2007 CSTIC LBLG COSMETLBLG COSMETLBLG India 429-0770973-9 13 8 Ravi Spice Processors Pvt. Ltd. Bangalore In-Ka, IN 560039 SEA-DO 53EY-01 BRYL CREAM DANDRUFF CONTROL 20-SEP-2007 CSTIC LBLG India DY2-0707022-7 2 29 Godrej Consumer Products Ltd Mumbai , IN 400079 SWI-DO 53FH-01 Permanent Hair Dye, Natural Black (18 g) 21-SEP-2007 COSMETLBLG Kenya 112-7838222-3 1 1 Abdi Hakim Nbo , KE NOL-DO 53FH-99 926314281465 HENNA 05-SEP-2007 UNSAFE COL Canada 551-7050644-3 2 1 D Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 BODY PAINT FOR TEMPORARY TATTOOS (DEMCO - 2 OZ BOTTLES) - VA 28-SEP-2007 COSMETLBLG Canada 551-7050644-3 2 1 C Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-04 BODY PAINT, FOR TEMPORARY TATTOOS (6 PC KIT) 28-SEP-2007 COSMETLBLG Canada 551-7050644-3 2 1 B Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-09 FACE PAINT MARKERS (BLUE COLOR) 28-SEP-2007 UNSAFE COL POISONOUS COSMETLBLG Canada 551-7050644-3 2 1 A Demco Manufacturing Inc Saint-hubert Quebec, CA J3Y2S3 NYK-DO 53GD-09 FACE PAINT MARKERS (WHITE COLOR) 28-SEP-2007 POISONOUS COSMETLBLG Thailand 417-0244671-1 18 1 Colgate Palmolive (Thailand) Co.,Ltd. Kongtoy , TH NYK-DO 53IC-01 TOOTH PASTE 20-SEP-2007 LABELING China 261-0449430-2 2 1 YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD. JIANGSU , CN 12345 SJN-DO 53IG-01 TOOTH PASTE 11-SEP-2007 NOT LISTED INCONSPICU Nigeria J50-0097872-4 5 1 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53IH-99 ASTHON TEETHING POWDER 13-SEP-2007 UNAPPROVED Guatemala 544-0321278-7 8 1 Industria Guatemalteca Kent S.A. Guatemala City , GT FLA-DO 53JK-02 DEODORANT 21-SEP-2007 NOT LISTED India AC1-7271520-6 2 1 Godrej Consumer Products Ltd Thana , IN SEA-DO 53JY-01 OLD CHINTAL SOAP 21-SEP-2007 COSMETLBLG India AC1-7271520-6 2 2 Hindustan Lever Ltd Solan , IN SEA-DO 53JY-01 REXONA SOAP 21-SEP-2007 COSM COLOR India AC1-7271520-6 2 4 Hindustan Lever Ltd Solan , IN SEA-DO 53JY-01 LUX SOAP 21-SEP-2007 COSM COLOR India AC1-7271520-6 2 7 Karnatka Soap & Detergents Ltd Banglore , IN 560055 SEA-DO 53JY-01 MYSORE SANDLE SOAP 21-SEP-2007 COSMETLBLG India AC1-7271520-6 2 9 Cholayil Ltd Tada , IN SEA-DO 53JY-01 MEDIMIX SOAP 21-SEP-2007 CSTIC LBLG COSMETLBLG France ALA-0020431-5 2 1 Parfums Christian Dior Paris , FR 75008 SJN-DO 53LC-01 CREME CORRECTION RIDES WRINKLE EYE CREAM- CAPTURE R60/80 YEU 27-SEP-2007 UNAPPROVED United States M96-2067107-0 1 1 LifeTech Resources Chatsworth, CA 91311-5101 LOS-DO 53LC-03 FACE CREAM 11-SEP-2007 NOT LISTED FALSE Mexico GV3-0705418-1 7 1 Industrializadora De Cacahuananche Sa De Cv Zapopan , Jalisco , MX 45220 SWI-DO 53LC-06 COLAGEN CREAM WITH VITAMIN E 06-SEP-2007 UNSAFE COL India WUG-0137360-3 9 2 Hindustan Lever Ltd. Mumbai IN-MH, IN 400708 LOS-DO 53LC-06 MultiVitamin - Total Fairness Cream 29-SEP-2007 UNAPPROVED India WUG-0137360-3 9 1 Hindustan Lever Ltd. Mumbai IN-MH, IN 400708 LOS-DO 53LC-06 MultiVitamin - Total Fairness Cream 29-SEP-2007 UNAPPROVED Nigeria J50-0097872-4 1 2 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LC-99 ANTI ACNE CREAM DERMORATE 13-SEP-2007 UNAPPROVED Nigeria J50-0097872-4 3 3 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LC-99 VISIBLE DIFFERENCE SKIN CREAM 13-SEP-2007 UNAPPROVED Nigeria J50-0097872-4 4 1 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LC-99 ANTI ICHING CREAM 13-SEP-2007 UNAPPROVED United Kingdom 946-0600448-2 52 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL ANTISEPTIC LIQUID 500ML 27-SEP-2007 NOT LISTED United Kingdom 946-0600448-2 51 1 Reckitt Benkiser Ltd Swindon , GB SN57XZ LOS-DO 53LC-99 DETTOL ANTISEPTIC LIQUID 250ML 27-SEP-2007 NOT LISTED Italy AW6-0072293-4 1 1 P Dpc Ltd Kowloon , HK SAN-DO 53LD-09 Refreshing Dermal Regulator 13-SEP-2007 UNSAFE COL COLOR LBLG Italy AW6-0072293-4 1 1 O Dpc Ltd Kowloon , HK SAN-DO 53LD-09 Refreshing Dermal Regulator 13-SEP-2007 UNSAFE COL CSTIC LBLG Nigeria J50-0097872-4 1 1 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LD-99 ANTI ACNE LOTION 13-SEP-2007 UNAPPROVED Belgium 804-0999183-5 3 1 B Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53LD-99 Lifting Bust Serum (glass bottles) 17-SEP-2007 NO ENGLISH UNAPPROVED Taiwan BLW-0520506-3 3 1 Hsin Ten Health & Wealth Int'L Taipei , TW LOS-DO 53LD-99 BIANCA BODY PROFILE BODY LOTION 24-SEP-2007 UNAPPROVED Japan EE6-1339086-7 3 1 Leo D'Or Trading Co Ltd Tokyo , JP 103 ATL-DO 53LF-01 HERBAL WRAP/PAD FOR SKIN CARE/CLEANSING. ALL NATURAL 25-SEP-2007 UNAPPROVED Japan 791-4298247-3 1 1 O'will Corporation Tokyo JP-13, JP 1020093 NYK-DO 53LF-06 CELLULITE PATCHES 05-SEP-2007 UNAPPROVED Japan 791-9429824-0 1 1 O'will Corporation Tokyo JP-13, JP 1020093 NYK-DO 53LF-06 CELLULITE PATCHES 05-SEP-2007 UNAPPROVED Guatemala 544-0321278-7 1 1 Globalpak, S.A. Villa Nueva , GT FLA-DO 53LH-09 MEDICATED TALC POWDER 21-SEP-2007 NOT LISTED Syrian Arab Republic DY2-0706270-3 2 13 Natural Cosmetics Products Damascus , SY SWI-DO 53LY-02 Hair Remover 12-SEP-2007 CSTIC LBLG Nigeria J50-0097872-4 3 1 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LY-99 FACIAL TONING GEL 13-SEP-2007 UNAPPROVED Nigeria J50-0097872-4 3 2 Virgin Fruit Cosmetics Stores Lagos , NG ATL-DO 53LY-99 HOT MOVATE GEL 13-SEP-2007 UNAPPROVED Israel TZ8-0903832-4 19 1 Minus 417 Cosmetic Research Dead Sea Ltd Bnei Brack , IL ATL-DO 53UD-13 SUN BLOCK - SPF 15 07-SEP-2007 NOT LISTED Israel TZ8-0903832-4 20 1 Minus 417 Cosmetic Research Dead Sea Ltd Bnei Brack , IL ATL-DO 53UD-13 SUN BLOCK - SPF 30 07-SEP-2007 NOT LISTED Israel TZ8-0903832-4 21 1 Minus 417 Cosmetic Research Dead Sea Ltd Bnei Brack , IL ATL-DO 53UD-13 SUN BLOCK - SPF 45 07-SEP-2007 NOT LISTED France 804-0999183-5 3 1 C Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53YC-99 Volumizing Bust Serum (glass bottles) 17-SEP-2007 NO ENGLISH UNAPPROVED France 804-0999183-5 3 1 D Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53YC-99 VOLUMIZING BUST SERUM (plastic tubes) 17-SEP-2007 DIRECTIONS UNAPPROVED France 804-0999183-5 3 1 E Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53YC-99 LIFTING BUST SERUM (plastic tubes) 17-SEP-2007 DIRECTIONS UNAPPROVED France 804-0999183-5 3 1 F Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53YC-99 BUST PEELING with Coconut Pulp 17-SEP-2007 DIRECTIONS DRUG NAME UNAPPROVED France 804-0999183-5 3 1 G Academie Scientifique De Beaute Colombes , FR 92700 SWI-DO 53YC-99 BUST MODELLING CREAM 17-SEP-2007 DIRECTIONS UNAPPROVED