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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-9555270-5/3/1

Manufacturer FEI3007832943
Manufacturer NameLubatti Ltd  
Manufacturer Address line 1Po Box 4136  
Manufacturer Address line 2  
Manufacturer's CityBracknell  
Manufacturer Province/StateBerkshire  
Manufacturer Country/AreaUnited Kingdom  
Product Code53CY99  
Importer's Product DescriptionANIT-AGE UPLIFTING EYE SERUM  
Refusal Date12-Mar-2013  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-9555270-5/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.