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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 112-8368095-2/7/1/D


Manufacturer FEI3006222866
Manufacturer NameRdl Cosmetics Laboratory Inc  
Manufacturer Address line 1Davao  
Manufacturer Address line 2  
Manufacturer's CityDavao City  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53LC01  
Importer's Product Description529037378370 LOTION  
Refusal Date31-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8368095-2/7/1/D
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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