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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-4725827-8/1/1

Manufacturer FEI3008759813
Manufacturer NameContac Travel Marketing  
Manufacturer Address line 16600 Dennett Place  
Manufacturer Address line 2  
Manufacturer's CityDelta  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53LD06  
Refusal Date20-Jan-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-4725827-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.