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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 101-3137757-4/8/1


Manufacturer FEI3009841078
Manufacturer NameSapat & Co. (Bombay) Pvt. Ltd.  
Manufacturer Address line 1102-103, T.V. Ind. Estate  
Manufacturer Address line 2  
Manufacturer's CityWorli  
Manufacturer Province/StateMumbai  
Manufacturer Country/AreaIndia  
Product Code53LD01  
Importer's Product DescriptionSAPAT LOTION  
Refusal Date30-Nov-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 101-3137757-4/8/1
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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