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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 ANP-0032095-3/2/1/F

Manufacturer FEI3005343638
Manufacturer NameDaiso Industries Co Ltd  
Manufacturer Address line 11-4-14 Higasni Yoshiyuki Saijyo  
Manufacturer Address line 2  
Manufacturer's CityHiroshima Ken  
Manufacturer Province/StateFN  
Manufacturer Country/AreaJapan  
Product Code53LC03  
Importer's Product DescriptionALOE SKIN CREAM  
Refusal Date21-Feb-2012  
FDA DistrictSAN-DO  
Entry/doc/line/sfx ANP-0032095-3/2/1/F
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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.