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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal 855-0039300-5/3/1/D


Manufacturer FEI3009685204
Manufacturer NameGreen Co Ltd  
Manufacturer Address line 17/1-2 Moo 7 Srinakarin Roadtumbol  
Manufacturer Address line 2  
Manufacturer's CityTumbol Bangmuang Ampormuang Samutprakan  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LY99  
Importer's Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.;NOT ELSEWHERE CLASSIFIE  
Refusal Date19-Oct-2012  
FDA DistrictNWE-DO  
Entry/doc/line/sfx 855-0039300-5/3/1/D
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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