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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 574-0267371-9/11/1

Manufacturer FEI3009505315
Manufacturer NameWala Dr. Hauschka  
Manufacturer Address line 1Bosslerweg 2  
Manufacturer Address line 2  
Manufacturer's CityBad Boll  
Manufacturer Province/StateBaden-w┬┐rttemberg  
Manufacturer Country/AreaGermany  
Product Code53LG08  
Importer's Product DescriptionFACIAL MASKS IN 30ML METAL TUBE  
Refusal Date11-Jun-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 574-0267371-9/11/1
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.