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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 D51-1123732-2/5/1

Manufacturer FEI3007615087
Manufacturer NameYangzhou Qianna Cosmetic Factroy  
Manufacturer Address line 1No 61 Tongda Road  
Manufacturer Address line 2  
Manufacturer's CityYangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53MD01  
Importer's Product DescriptionSUN LOTION  
Refusal Date11-May-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx D51-1123732-2/5/1
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.