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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 AM5-6624545-3/8/1/I

Manufacturer FEI3000243267
Manufacturer NameLogona Naturkosmetik Und Heilmittel Hans Hansel Gmbh  
Manufacturer Address line 1Unknown Street  
Manufacturer Address line 2  
Manufacturer's CitySalzhemmendorf  
Manufacturer Province/State  
Manufacturer Country/AreaGermany  
Product Code53CK02  
Refusal Date15-Jun-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx AM5-6624545-3/8/1/I
FDA Sample AnalysisNo  
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).