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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 E8L-1013229-3/6/1


Manufacturer FEI3010165609
Manufacturer NameInel Cosmetics Co., Ltd.  
Manufacturer Address line 1463 Baekjegobun-ro  
Manufacturer Address line 2Songpagu  
Manufacturer's CitySeoul  
Manufacturer Province/StateSeoul  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date10-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx E8L-1013229-3/6/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
FRNMFGREG   502(o), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&CA. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act. [Misbranding, Section 502(o), 801(a)(3)].  
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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