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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 112-7971750-2/1/1


Manufacturer FEI3006269730
Manufacturer NameRohto Pharmaceutical Co Ltd  
Manufacturer Address line 16 5 1 3 Kunimidai  
Manufacturer Address line 2  
Manufacturer's CityKizugawa-City  
Manufacturer Province/State  
Manufacturer Country/AreaJapan  
Product Code53LD06  
Importer's Product Description859955468594 MOISTURIZER  
Refusal Date07-Jan-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-7971750-2/1/1
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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