• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal ABT-0772448-9/1/1

Manufacturer FEI3008293803
Manufacturer NameAthena Guangzhou Cosmetics Manufacturer Co. Ltd  
Manufacturer Address line 1126 Dongping North Rd. Baiyun  
Manufacturer Address line 2  
Manufacturer's CityGuangzhou  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code53LC01  
Importer's Product DescriptionLILAC ACNE SERUM  
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  
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.