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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 KR3-0110830-3/1/2

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 TEPEZCOHUITLE  
Refusal Date30-Apr-2012  
FDA DistrictSWI-DO  
Entry/doc/line/sfx KR3-0110830-3/1/2
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).