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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 112-7507365-3/1/3

Manufacturer FEI3009533323
Manufacturer NameTangherlini Rosa  
Manufacturer Address line 1Via Strada Nuova 59/A  
Manufacturer Address line 2  
Manufacturer's CityCaorle  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code53MD01  
Importer's Product Description798339146295 /SUN LOTION  
Refusal Date29-Jun-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7507365-3/1/3
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.