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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-8484244-8/1/37

Manufacturer FEI3002409942
Manufacturer NameCellex-C International  
Manufacturer Address line 1146 Davenport Avenue  
Manufacturer Address line 2  
Manufacturer's CityToronto  
Manufacturer Province/StateON  
Manufacturer Country/AreaCanada  
Product Code53LY01  
Importer's Product DescriptionNON TOXIC COSMETICS MOISTURIZERS- 30ML  
Refusal Date28-Nov-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-8484244-8/1/37
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).