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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 ABT-0772448-9/1/1


Manufacturer FEI3008206113
Manufacturer NameAthena Guangzhou Cosmetics Manufacturer Co. Ltd  
Manufacturer Address line 1126 Dongping North Rd.  
Manufacturer Address line 2Baiyun District  
Manufacturer's CityGuangzhou  
Manufacturer Province/StateGuangdong  
Manufacturer Country/AreaChina  
Product Code53LC01  
FDA Product DescriptionCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)  
Refusal Date22-Feb-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx ABT-0772448-9/1/1
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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