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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 112-8579268-0/2/1/B


Manufacturer FEI3005002056
Manufacturer NameLiberty Healthcare  
Manufacturer Address line 1Leestraat 12  
Manufacturer Address line 2  
Manufacturer's CityBaarn  
Manufacturer Province/StateNL-UT  
Manufacturer Country/AreaNetherlands  
Product Code53LD99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date07-Sep-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-8579268-0/2/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
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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