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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-0008457-3/6/1


Manufacturer FEI3005421272
Manufacturer NamePsalmstre Enterprises  
Manufacturer Address line 1Unit 503, 5th fl. Jmj Bldg.  
Manufacturer Address line 2P, Sanchezcor. Pat.  
Manufacturer's CityMetro Manila  
Manufacturer Province/State  
Manufacturer Country/AreaPhilippines  
Product Code53JK01  
FDA Product DescriptionBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date19-Mar-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BXM-0008457-3/6/1
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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