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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 U83-0533601-7/1/1


Manufacturer FEI3009015612
Manufacturer NameAcces Trading Sac  
Manufacturer Address line 1Av. Santa Cruz 1310 Miraflores  
Manufacturer Address line 2  
Manufacturer's CityLima  
Manufacturer Province/State  
Manufacturer Country/AreaPeru  
Product Code53LC03  
Importer's Product DescriptionCAT'S CLAW FACE OINTMENT  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx U83-0533601-7/1/1
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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