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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 M21-0747622-0/1/3


Manufacturer FEI3002989319
Manufacturer NameCATALYSIS, S.L.  
Manufacturer Address line 1Calle Macarena 14  
Manufacturer Address line 2  
Manufacturer's CityMadrid  
Manufacturer Province/StateMadrid  
Manufacturer Country/AreaSpain  
Product Code53GK99  
FDA Product DescriptionOTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.  
Refusal Date28-Mar-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx M21-0747622-0/1/3
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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