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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 UPS-4317869-4/4/15

Manufacturer FEI3008995240
Manufacturer NameMateriel Medical And Co  
Manufacturer Address line 1594 Chemin De La Sourceespace Lumiere  
Manufacturer Address line 2  
Manufacturer's CityHyereshyeres  
Manufacturer Province/State  
Manufacturer Country/AreaFrance  
Product Code53LD06  
Refusal Date12-Dec-2011  
FDA DistrictPHI-DO  
Entry/doc/line/sfx UPS-4317869-4/4/15
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.