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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 CFP-0009901-7/2/1

Manufacturer FEI3004188169
Manufacturer NameOtc Pharma Interna  
Manufacturer Address line 1Edisonweg 22  
Manufacturer Address line 2  
Manufacturer's CityGorinchem  
Manufacturer Province/State  
Manufacturer Country/AreaNetherlands  
Product Code53ED07  
Importer's Product DescriptionSWISSCARE HAIRGROW LOTION 200 ML  
Refusal Date28-Mar-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx CFP-0009901-7/2/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSMETLBLG   5(c)(3)(A); 801(a)(3) Misbranding   It appears the label does not bear the common or usual name of the cosmetic.