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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 045-0325775-2/2/2


Manufacturer FEI3008511635
Manufacturer NameEris Cosmetics  
Manufacturer Address line 1Ul Armii Krajowej 12  
Manufacturer Address line 2  
Manufacturer's CityPiaseczno  
Manufacturer Province/State  
Manufacturer Country/AreaPoland  
Product Code53ED06  
FDA Product DescriptionSHAMPOOS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date08-Jan-2013  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 045-0325775-2/2/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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