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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-7176553-4/49/1

Manufacturer FEI3008630152
Manufacturer NameThe Green People Company Limited  
Manufacturer Address line 1Pondtail Farm Coolham Road  
Manufacturer Address line 2  
Manufacturer's CityWest Grinstead  
Manufacturer Province/StateWest Sussex  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LD06  
Importer's Product Description7 ACTIVE FIX REPAIR SERUM  
Refusal Date28-Sep-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx UPS-7176553-4/49/1
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.