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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 371-4229050-3/1/2/C

Manufacturer FEI3007330486
Manufacturer NameDr. Babor GMBH & Co. KG  
Manufacturer Address line 1Neuenhofstrasse #180  
Manufacturer Address line 2  
Manufacturer's CityAachen  
Manufacturer Province/StateNordrhein-westfalen  
Manufacturer Country/AreaGermany  
Product Code53LY03  
Importer's Product DescriptionSKIN CARE PREP.-LOTION,SERUM,FLUID  
Refusal Date13-Jan-2012  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 371-4229050-3/1/2/C
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.