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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 SQ4-0073175-9/5/4


Manufacturer FEI3009103562
Manufacturer NameAttirance Sia  
Manufacturer Address line 1332b Maskavas Street  
Manufacturer Address line 2  
Manufacturer's CityRiqa  
Manufacturer Province/State  
Manufacturer Country/AreaLatvia  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date04-Nov-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx SQ4-0073175-9/5/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS FIRM   403(e)(1), 801(a)(3); MISBRANDING   The food is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
LIST INGRE   403(i)(2), 801(a)(3); MISBRANDING   It appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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