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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 K80-1017210-5/7/1


Manufacturer FEI3009003983
Manufacturer NameTARGET EXPORTS PVT LTD  
Manufacturer Address line 1F-196AP PHASE VIII FOCAL POINT  
Manufacturer Address line 2  
Manufacturer's CityLudhiana  
Manufacturer Province/StatePunjab  
Manufacturer Country/AreaIndia  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date06-Feb-2013  
FDA DistrictSAN-DO  
Entry/doc/line/sfx K80-1017210-5/7/1
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.  
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