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