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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 BDX-0050169-5/2/1/B


Manufacturer FEI3008636676
Manufacturer NameL-Tec Pharmachem Co., Ltd.  
Manufacturer Address line 1150-6 Ogeum-Dong, Songpa-Gu  
Manufacturer Address line 2  
Manufacturer's CitySeoul  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53JK01  
FDA Product DescriptionBATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)  
Refusal Date25-Jan-2012  
FDA DistrictNYK-DO  
Entry/doc/line/sfx BDX-0050169-5/2/1/B
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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