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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 112-8448968-4/2/4


Manufacturer FEI3004989717
Manufacturer NameAble C & C Co., Ltd.  
Manufacturer Address line 1A-3FL Sk Twin Tech Tower,  
Manufacturer Address line 2345-9 Gasan-Dong Gsumcheon-Gu  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC10  
Importer's Product Description899175037944 PERFECT COVER CREAM,HEALINGVISIBLE WRINKLE & BLEM SPF42PA  
Refusal Date26-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-8448968-4/2/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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