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 110-0707733-8 1 5
Pharmacy2u
Leedsleeds , GB LS14 1PQ PHI-DO
53BH-01 DEAD SEA SPA BATH SALTS PERSONAL USE DORIS JOHNSON
28-NOV-2007 HEALTH C
Germany 112-8853665-1 4 1
Long Time Liner
Zurich , DE NOL-DO
53CD-02 859020952291 LTL PENCIL
07-NOV-2007 UNSAFE COL
CSTIC LBLG
France 112-8795759-3 1 1
Orgev Laboratoires
Rambouillet , FR 78120 NOL-DO
53CD-04 862506876384 Eyes Lift Serum
07-NOV-2007 CSTIC LBLG
Germany 112-8853665-1 1 1
Long Time Liner
Zurich , DE NOL-DO
53CD-07 859020952291 EYEBROW COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
United Kingdom 112-8300445-7 5 1
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYESHADOW
13-NOV-2007 POISONOUS
United Kingdom 112-8300445-7 5 2
Coty Manufacturing UK Ltd.
Ashford Kent, GB TN25 4AQ NYK-DO
53CH-03 EYESHADOW
13-NOV-2007 POISONOUS
Taiwan 112-8894219-8 1 1
Cosmetics Tech Co.,
Kaohsiung , TW CHI-DO
53CH-03 PARADISE GREENS
19-NOV-2007 COSM COLOR
Taiwan 112-8894219-8 2 1
Cosmetics Tech Co.,
Kaohsiung , TW CHI-DO
53CH-03 WATER COLORS
19-NOV-2007 COSM COLOR
Taiwan 112-8894219-8 3 1
Cosmetics Tech Co.,
Kaohsiung , TW CHI-DO
53CH-03 NEUTRAL TONES
19-NOV-2007 COSM COLOR
Pakistan K74-0141656-8 38 1
Kzk Industrial & Commercial Co.
Karachi , PK CHI-DO
53CK-02 EYE LINER (KAJAL) TRADITIONAL EYE-LINER(PEN
13-NOV-2007 COSM COLOR
India WUG-0123852-5 8 1
Gayatri Masala Exporter
Nadiad IN-GJ, IN 387001 LOS-DO
53CY-02 KAJAL
05-NOV-2007 COSM COLOR
Dominican Republic 516-2033570-6 1 1
Laboratorios Key C Por A
Santo Domingo , DO NYK-DO
53ED-01 HAIR CONDITIONERS
29-NOV-2007 UNSAFE COL
Dominican Republic 516-2033570-6 3 1
Laboratorios Key C Por A
Santo Domingo , DO NYK-DO
53ED-06 SHAMPOOS
29-NOV-2007 UNSAFE COL
Dominican Republic 516-2033570-6 2 1
Laboratorios Key C Por A
Santo Domingo , DO NYK-DO
53EY-99 HAIR PREPARATIONS
29-NOV-2007 UNSAFE COL
Germany 112-8853665-1 2 1
Long Time Liner
Zurich , DE NOL-DO
53GD-05 859020952295 LIP COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
Germany 112-8853665-1 4 2
Long Time Liner
Zurich , DE NOL-DO
53GD-05 859020952291 LIP COLOUR
07-NOV-2007 UNSAFE COL
CSTIC LBLG
China ACN-1059800-9 2 2
Yangzhou Youchuanhao Tourist Produc
Hangji Yangchuan City , CN LOS-DO
53IC-01 UNFLOURINATED TOOTHPASTE, SGS TEST CERTIFIED/NO DIETHYLENE G
30-NOV-2007 POISONOUS
Thailand XXX-0152485-0 1 1 A
Helpcare Enterprise
Penang , MY NYK-DO
53ID-01 Toothpaste with Floride Fresh Stripe Gel
13-NOV-2007 NOT LISTED
DIRECTIONS
Thailand XXX-0152485-0 1 1 B
Helpcare Enterprise
Penang , MY NYK-DO
53ID-01 Toothpaste with Floride Clean Mint Paste
13-NOV-2007 NOT LISTED
UNAPPROVED
Thailand XXX-0152485-0 1 1 C
Helpcare Enterprise
Penang , MY NYK-DO
53ID-01 Toothpaste with Floride Icy Cool Mint Paste
13-NOV-2007 NOT LISTED
UNAPPROVED
Hong Kong SAR 700-0116566-4 4 1
Product Plus Ltd
Kowloon , HK LOS-DO
53IG-01 FIRST CLASS AMENITY KITS, TOOTHPASTE
14-NOV-2007 NOT LISTED
REGISTERED
UNAPPROVED
Hong Kong SAR 700-0116566-4 13 1
Product Plus Ltd
Kowloon , HK LOS-DO
53IG-01 BUSINESS CLASS AMENITY KITS, TOOTHPASTE
14-NOV-2007 NOT LISTED
REGISTERED
UNAPPROVED
Korea, Republic Of (South) WRE-0353975-6 6 1
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO
53IG-01 NANO TOOTHPASTE
15-NOV-2007 UNAPPROVED
Korea, Republic Of (South) WRE-0353975-6 6 2
DongSung Pharm.Co.,Ltd
Seoul KR-NOTA, KR 132-853 LOS-DO
53IG-01 INDAN TOOTHPASTE
15-NOV-2007 UNAPPROVED
India WUG-0139181-1 16 1
J. D. Corporation
Mumbai , IN LOS-DO
53IG-01 Toothpaste Babool (Natural strength for teeth)
28-NOV-2007 NOT LISTED
China M94-0047527-0 2 1
Yangzhou Maple Imp&Exp Corp
Yangzhou , CN FLA-DO
53JI-02 DEODORANT
01-NOV-2007 LABELING
Netherlands Antilles JF7-0059227-8 1 1
Elko Org. Ltd.
San Viltore , CH FLA-DO
53LC-01 CREAM MOISTURIZER
14-NOV-2007 UNAPPROVED
Germany 112-8741218-5 1 1 B
Vitalize Health Products Ltd
Surbiton GB-SRY, GB KT58LQ NOL-DO
53LC-03 857073611011 Revitalizing Treatment and Night Cream
05-NOV-2007 COSM COLOR
United States 946-0600587-7 1 3
Spectrum Cosmetics
Commerce, CA 90040-3216 LOS-DO
53LC-06 MOISTURIZING (SKIN CARE PREPARATIONS);CREAM;
14-NOV-2007 NOT LISTED
United Kingdom MA7-0629415-8 10 1 B
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO
53LD-06 Anti wrinkle gel
13-NOV-2007 COSMETLBLG
India 112-6774122-3 1 1 A
Target Logistiics
Vijayawada , IN 520001 NOL-DO
53LD-99 Cosmetics
14-NOV-2007 COSMETLBLG
Japan EE6-1339917-3 4 1
Leo D'Or Trading Co Ltd
Tokyo , JP 103 ATL-DO
53LF-01 HERBAL WRAP/PAD FOR SKIN CARE/CLEANSING
30-NOV-2007 UNAPPROVED
Spain WJD-0027503-0 1 3 L
Bio-Col S.L.
Barcelona , ES FLA-DO
53LY-01 Cleansing Gel w/Oats
15-NOV-2007 UNSAFE COL
United Kingdom MA7-0629415-8 15 1
Steiner Transocean Ltd
Middx , GB HA36BZ FLA-DO
53MC-01 TANNING LOTION
13-NOV-2007 COSMETLBLG
Poland 322-3362825-7 1 1
Pphu Aroma Trend Piotr Draniak
Michalowice , PL 05-816 LOS-DO
53MD-02 MASA COOLING BRONZER
14-NOV-2007 DIRECTIONS
COSMETIC
LACKS FIRM
LACKS N/C
Poland 322-3362825-7 2 1
Pphu Aroma Trend Piotr Draniak
Michalowice , PL 05-816 LOS-DO
53MD-02 MASA TRIPLE BRONZER
14-NOV-2007 DIRECTIONS
COSMETIC
LACKS N/C
LACKS FIRM
Colombia 112-8874726-6 9 1
Laboratorios Dermanat S.A.
Cali , CO NOL-DO
53RC-12 862765706769 COSMETIC SKIN CARE
07-NOV-2007 CSTIC LBLG