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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 112-4856381-4/1/3

Manufacturer FEI3008179153
Manufacturer NamePai Skincare Limited  
Manufacturer Address line 111 Devonshire Mewsgatwick Roadlondon  
Manufacturer Address line 2  
Manufacturer's CityLondonlondon  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LC03  
Importer's Product Description797693048802 FRAGONLA & SEA BUCKTHORN HAND CREAM  
Refusal Date09-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4856381-4/1/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.