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