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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 D68-0135675-2/3/1

Manufacturer FEI3009429164
Manufacturer NameEuropa Plus  
Manufacturer Address line 1Korniychuka Vul 4 Suite 94  
Manufacturer Address line 2  
Manufacturer's CityDnipropetrovsk  
Manufacturer Province/StateDnipropetrovska  
Manufacturer Country/AreaUkraine  
Product Code53ED99  
Refusal Date20-Dec-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx D68-0135675-2/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
NO ENGLISH   502(c); 801(a)(3) ;MISBRANDING   Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).  
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).