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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 700-0682126-1/10/1

Manufacturer FEI3009621920
Manufacturer NameParrs Products Limited  
Manufacturer Address line 13 Portage Road, New Lynn  
Manufacturer Address line 2  
Manufacturer's CityAuckland  
Manufacturer Province/State  
Manufacturer Country/AreaNew Zealand  
Product Code53LD03  
Importer's Product DescriptionMANUKA HONEY FACIAL SERUM  
Refusal Date18-Jul-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 700-0682126-1/10/1
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.