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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 112-9166913-7/1/1

Manufacturer FEI3005880964
Manufacturer NameRovi Cosmetics Intern. Gmbh  
Manufacturer Address line 1Breitwiesenstrasse 1  
Manufacturer Address line 2  
Manufacturer's CitySchluchtern  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53PD99  
Importer's Product Description796295862012/ ROVISOME RETINOL MOIST RAW MATERIAL FOR COSMETICS  
Refusal Date26-Apr-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-9166913-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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.  
FILTH   601(b), 801(a)(3); ADULTERATION   The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.  
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