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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 EDR-0027888-5/1/1


Manufacturer FEI3008466399
Manufacturer NameGenomma Lab Internacional SAB de CV  
Manufacturer Address line 1Av Industrial Automotriz,  
Manufacturer Address line 2Esq Ind Pte MZ 4 LT 3 y 5,  
Manufacturer's CityEstado de Mexico  
Manufacturer Province/StateDona Rosa Lerma  
Manufacturer Country/AreaMexico  
Product Code53LG01  
FDA Product DescriptionCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)  
Refusal Date12-Oct-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx EDR-0027888-5/1/1
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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