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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 112-9138836-6/2/2


Manufacturer FEI3008935624
Manufacturer NameBio Woman Co Ltd  
Manufacturer Address line 1256 258 260 Ladprao 132  
Manufacturer Address line 2  
Manufacturer's CityBangkok  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LD99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date29-Oct-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-9138836-6/2/2
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.  
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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