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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 234-0336477-3/6/4


Manufacturer FEI3003933402
Manufacturer NameRegisco Ent  
Manufacturer Address line 1Po Box Md 5 Madina  
Manufacturer Address line 2  
Manufacturer's CityAccra  
Manufacturer Province/State  
Manufacturer Country/AreaGhana  
Product Code53LC03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date10-Aug-2004  
FDA DistrictNYK-DO  
Entry/doc/line/sfx 234-0336477-3/6/4
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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