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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 DR4-0186060-3/3/1

Manufacturer FEI3006502076
Manufacturer NameREJUVENTUM, SA DE CV  
Manufacturer Address line 1CALLEJON ZARAGOZA NO 1  
Manufacturer Address line 2  
Manufacturer's CityMEXICO  
Manufacturer Province/StateMX-DIF  
Manufacturer Country/AreaMexico  
Product Code53LF01  
Importer's Product DescriptionCHIN & NECK APPLICATOR  
Refusal Date22-Jun-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx DR4-0186060-3/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.