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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 BXM-0008457-3/60/1

Manufacturer FEI3004096041
Manufacturer NameSplash Corporation  
Manufacturer Address line 1No. 17 F. Lazaro Street Canumay West  
Manufacturer Address line 2  
Manufacturer's CityValenzuela City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53LD03  
Importer's Product DescriptionMAXI PEEL RED EXFOLIANT #1 - 60ML  
Refusal Date19-Mar-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BXM-0008457-3/60/1
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.