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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 300-5938082-2/71/1


Manufacturer FEI3009795513
Manufacturer NameLes Productions Pupazzo  
Manufacturer Address line 1788 Avenue Greene  
Manufacturer Address line 2  
Manufacturer's CityMontreal  
Manufacturer Province/StateQUEBEC  
Manufacturer Country/AreaCanada  
Product Code53AD02  
Importer's Product DescriptionSOOTHING FACE AND BODY MILK  
Refusal Date02-Jan-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 300-5938082-2/71/1
FDA Sample AnalysisYes  
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.  
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.  
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