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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-6366957-2/4/1/H


Manufacturer FEI3005769953
Manufacturer NameSedna International  
Manufacturer Address line 15435 J Armand Bombardier  
Manufacturer Address line 2  
Manufacturer's CitySt Hubertst Hubert  
Manufacturer Province/StateQUEBEC  
Manufacturer Country/AreaCanada  
Product Code53LD10  
FDA Product DescriptionWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)  
Refusal Date03-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-6366957-2/4/1/H
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
UNSAFE COL   402(c), 801(a)(3); ADULTERATION   The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).  
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