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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 EJ2-0111040-3/2/1/B


Manufacturer FEI3008846287
Manufacturer NameCUCKU ENTERPRISES PVT. LTD.  
Manufacturer Address line 1G-12, JAWAHAR NAGAR,  
Manufacturer Address line 2  
Manufacturer's CityDelhi  
Manufacturer Province/StateDelhi  
Manufacturer Country/AreaIndia  
Product Code53IG01  
FDA Product DescriptionDENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)  
Refusal Date23-Apr-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx EJ2-0111040-3/2/1/B
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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