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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 T40-0763916-3/11/2

Manufacturer FEI3008784744
Manufacturer NameJaldhara Super Market  
Manufacturer Address line 1B-18 Sector-21  
Manufacturer Address line 2District Shopping Centre  
Manufacturer's CityGandhinagar  
Manufacturer Province/StateGujarat  
Manufacturer Country/AreaIndia  
Product Code53LD01  
Importer's Product DescriptionDETTOL  
Refusal Date17-Jul-2012  
FDA DistrictATL-DO  
Entry/doc/line/sfx T40-0763916-3/11/2
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.