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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 112-2950157-7/1/4

Manufacturer FEI3009000029
Manufacturer NameCuration Healthcare Pvt Ltd  
Manufacturer Address line 178/88 Defence Officers Colony  
Manufacturer Address line 2  
Manufacturer's CityChennai  
Manufacturer Province/State  
Manufacturer Country/AreaIndia  
Product Code53LC01  
Importer's Product Description873484784128 FOAM GEL  
Refusal Date26-Apr-2012  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-2950157-7/1/4
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.