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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 G08-0028237-1/11/5


Manufacturer FEI3004347567
Manufacturer NameWHITMAN LABORATORIES LTD.  
Manufacturer Address line 1Bedford Road  
Manufacturer Address line 2GU323DD  
Manufacturer's CityPETERSFIELD  
Manufacturer Province/StateHampshire  
Manufacturer Country/AreaUnited Kingdom  
Product Code53LD03  
FDA Product DescriptionFACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)  
Refusal Date29-Feb-2012  
FDA DistrictMIN-DO  
Entry/doc/line/sfx G08-0028237-1/11/5
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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