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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 112-8624549-8/3/1

Manufacturer FEI3009655171
Manufacturer NameFlores Natural Cosmetics Bv  
Manufacturer Address line 1Haatlandersdijk 24  
Manufacturer Address line 2  
Manufacturer's CityAr Kampen  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands  
Product Code53LD01  
Importer's Product Description852856670496 SPOTPEN  
Refusal Date17-Aug-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8624549-8/3/1
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.  
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).