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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-4261450-7/1/1


Manufacturer FEI3002808845
Manufacturer NameHolopack Verpackungstechnik GmbH (Site 1)  
Manufacturer Address line 1Sites 1 and 2  
Manufacturer Address line 2Bahnhofstrasse  
Manufacturer's CitySulzbach-laufen  
Manufacturer Province/StateBaden-wurttemberg  
Manufacturer Country/AreaGermany  
Product Code53LY10  
FDA Product DescriptionWRINKLE SMOOTHING (SKIN CARE PREPARATIONS)  
Refusal Date30-Jul-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx UPS-4261450-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FALSE   502(a), 801(a)(3); MISBRANDING   The labeling for this article appears to be false or misleading  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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