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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 CAY-1028054-0/23/1


Manufacturer FEI3008690064
Manufacturer NameNesura Cosmetics  
Manufacturer Address line 1285-1 Jwagyo-Ri , Godeok-Myeon  
Manufacturer Address line 2  
Manufacturer's CityPyeong Taek Si  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LC03  
Importer's Product DescriptionBLOCK & BLOCK ORIGINAL SUN CREAM  
Refusal Date10-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx CAY-1028054-0/23/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRECTIONS   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use.  
DRUG NAME   502(e)(1); 801(a)(3); Misbranding   The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.  
LACKS N/C   502(b)(2), 801(a)(3); MISBRANDING   The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.  
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
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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