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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 CCW-0009736-5/2/1


Manufacturer FEI3009215532
Manufacturer NameNeuphase, Sa De Cv  
Manufacturer Address line 1Monte Casino No 125  
Manufacturer Address line 2  
Manufacturer's CityMexico  
Manufacturer Province/State  
Manufacturer Country/AreaMexico  
Product Code53LD01  
FDA Product DescriptionCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)  
Refusal Date16-Dec-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx CCW-0009736-5/2/1
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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