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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 112-7806950-0/1/1

Manufacturer FEI3009565045
Manufacturer NameBiotarin  
Manufacturer Address line 1Stadionstrabe 1 C  
Manufacturer Address line 2  
Manufacturer's CityBambach  
Manufacturer Province/State  
Manufacturer Country/AreaAustria  
Product Code53LD03  
Importer's Product Description793571049130 LIFTING SERUM  
Refusal Date03-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7806950-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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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