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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 KR3-0114258-3/1/3

Manufacturer FEI3009201645
Manufacturer NameComercializadora Quality Health S.A  
Manufacturer Address line 1Fermin G Riestra 43  
Manufacturer Address line 2  
Manufacturer's CityZona Centro  
Manufacturer Province/StateJal  
Manufacturer Country/AreaMexico  
Product Code53LC01  
Importer's Product DescriptionOINTMENT MILAGRO  
Refusal Date12-Jul-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR3-0114258-3/1/3
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
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.