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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 112-8259145-7/6/1


Manufacturer FEI3005742067
Manufacturer NameAl Harmoodi Computer Systems  
Manufacturer Address line 1Murshed Bazar  
Manufacturer Address line 2  
Manufacturer's CityDubai  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Arab Emirates  
Product Code53DD02  
FDA Product DescriptionPERFUMES (FRAGRANCE PREPARATIONS)  
Refusal Date31-Jul-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8259145-7/6/1
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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