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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 ES2-0200547-7/16/61


Manufacturer FEI3010079337
Manufacturer NameBotanicus, Spol S.R.O.  
Manufacturer Address line 1Ostra 8 289 22 Lysa  
Manufacturer Address line 2  
Manufacturer's CityNad Labem  
Manufacturer Province/State  
Manufacturer Country/AreaCzech Republic  
Product Code53BD02  
Importer's Product DescriptionSOAP BIO SHEA BUTTER + PLUM  
Refusal Date17-Apr-2013  
FDA DistrictSEA-DO  
Entry/doc/line/sfx ES2-0200547-7/16/61
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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