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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 438-0810948-2/2/4

Manufacturer FEI3003079200
Manufacturer NameContinental Farmaceutica  
Manufacturer Address line 1Calle Jacinto Manon No 8  
Manufacturer Address line 2  
Manufacturer's CitySanto Domingo  
Manufacturer Province/State  
Manufacturer Country/AreaDominican Republic  
Product Code53LC03  
Importer's Product DescriptionFACIAL CREAM "CREMA DERMALINE"  
Refusal Date23-Mar-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 438-0810948-2/2/4
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DANGEROUS   502(j), 801(a)(3); MISBRANDING   The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.