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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 UPS-7280421-0/1/13


Manufacturer FEI3008475113
Manufacturer NameTonymoly Co.,Ltd  
Manufacturer Address line 12-3f Nonghyup Bldg., 813-5 Bangbae-Dong  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD01  
Importer's Product DescriptionBEAUTY PRODUCTS, COLLAGEN LOTION, DELV TO AS COSMETICS, NEW YORK, NY  
Refusal Date09-Aug-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-7280421-0/1/13
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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