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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 BBH-3012890-0/1/1

Manufacturer FEI3008846426
Manufacturer NameBie-Dro Pharm Handelsgesellschaft C Nuyken Kg  
Manufacturer Address line 1Industriestr 38  
Manufacturer Address line 2  
Manufacturer's CityBielefeld  
Manufacturer Province/StateNordrhein-westfalen  
Manufacturer Country/AreaGermany  
Product Code53LD09  
Importer's Product DescriptionPENATEN CREAM  
Refusal Date18-Apr-2012  
FDA DistrictCHI-DO  
Entry/doc/line/sfx BBH-3012890-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
COSMETLBLG   5(c)(3)(B); 801(a)(3) Misbranding   It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.  
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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