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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-0009901-7/3/1

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 Code53ED06  
Importer's Product DescriptionSWISSCARE HAIRGROW SHAMPOO 200 ML  
Refusal Date28-Mar-2013  
FDA DistrictFLA-DO  
Entry/doc/line/sfx CFP-0009901-7/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.