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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 UPS-3522703-6/3/1

Manufacturer FEI3003690512
Manufacturer NameLes Emballages Knowlton Inc.  
Manufacturer Address line 1315 Knowlton Road  
Manufacturer Address line 2Lac Brome  
Manufacturer's CityKnowlton  
Manufacturer Province/StateQuebec  
Manufacturer Country/AreaCanada  
Product Code53AD02  
Importer's Product DescriptionAV CALM/CMFT BABY LTN  
Refusal Date17-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-3522703-6/3/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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.