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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 U47-0490395-2/12/1

Manufacturer FEI3008616485
Manufacturer NameBalkanpharma-Troyan AT  
Manufacturer Address line 11 Krayrechna street  
Manufacturer Address line 2  
Manufacturer's CityTrojan  
Manufacturer Province/StateBG-NOTA  
Manufacturer Country/AreaBulgaria  
Product Code53LC06  
Importer's Product DescriptionCOSMETICS CREME  
Refusal Date09-May-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx U47-0490395-2/12/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use, and the article does not appear to be exempt from such requirements.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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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