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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 MR5-2023402-9/4/1

Manufacturer FEI3009621061
Manufacturer NameAtomy Canada Distribution Inc.  
Manufacturer Address line 1221 - 1024 Ridgeway Ave.  
Manufacturer Address line 2  
Manufacturer's CityCoquitlam  
Manufacturer Province/StateBRITISH COLUMBIA  
Manufacturer Country/AreaCanada  
Product Code53ED01  
Importer's Product DescriptionHAIR TONIC  
Refusal Date27-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx MR5-2023402-9/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.