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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 AEK-0617874-9/1/1


Manufacturer FEI3009876136
Manufacturer NameAnt Power Electron  
Manufacturer Address line 1B 4/F Tak Wing  
Manufacturer Address line 2  
Manufacturer's CityHon  
Manufacturer Province/State  
Manufacturer Country/AreaHong Kong SAR  
Product Code53LD03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date15-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-0617874-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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