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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-9168121-9/1/1


Manufacturer FEI3009291098
Manufacturer NameLadies Biotech Co Ltd  
Manufacturer Address line 114f No 679ming Cheng 3rd Rdku Shan Dist  
Manufacturer Address line 2  
Manufacturer's CityKaohsiung Citykaohsiung City  
Manufacturer Province/State  
Manufacturer Country/AreaTaiwan  
Product Code53LD08  
Importer's Product DescriptionANTI ACNE MASK GEL  
Refusal Date04-Feb-2013  
FDA DistrictCIN-DO  
Entry/doc/line/sfx UPS-9168121-9/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.  
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