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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 UPS-9285125-8/1/2


Manufacturer FEI3007840990
Manufacturer NameGW Cosmetics Gmbh  
Manufacturer Address line 1Achauerstrasse 49a, 2333  
Manufacturer Address line 2  
Manufacturer's CityLeopoldsdorf  
Manufacturer Province/StateNiederoesterreich  
Manufacturer Country/AreaAustria  
Product Code53CD99  
Importer's Product DescriptionSALINE SOLUTION  
Refusal Date19-Feb-2013  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-9285125-8/1/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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).  
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