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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 AEK-0774466-3/1/1


Manufacturer FEI3004580041
Manufacturer NameZheng Xing Zhangguang  
Manufacturer Address line 11701 Hanwei Guanghua Road  
Manufacturer Address line 2  
Manufacturer's CityPeking  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53ED06  
FDA Product DescriptionSHAMPOOS (HAIR PREPARATIONS, NON-COLORING)  
Refusal Date15-Jan-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AEK-0774466-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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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