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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-3953730-9/1/1


Manufacturer FEI3009161212
Manufacturer NameHeaven Health And Beauty Ltd  
Manufacturer Address line 113a Market Place  
Manufacturer Address line 2  
Manufacturer's CityShifnal  
Manufacturer Province/StateShropshire  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LC10  
FDA Product DescriptionWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)  
Refusal Date31-Oct-2011  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-3953730-9/1/1
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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