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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-4192433-9/1/1/D


Manufacturer FEI3004080362
Manufacturer NameNutra Reaserch Int'L , Ltd  
Manufacturer Address line 111911 Machrina Way  
Manufacturer Address line 2  
Manufacturer's CityRichmond  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53LD06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date31-Jan-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-4192433-9/1/1/D
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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