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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 112-4813658-7/4/1/P


Manufacturer FEI3002574623
Manufacturer NameUnilever India Export Ltd.  
Manufacturer Address line 1Plot 253-257, Sector-IV,  
Manufacturer Address line 2Kandla Special Economic Zone  
Manufacturer's CityGandhidham  
Manufacturer Province/StateGujaarat  
Manufacturer Country/AreaIndia  
Product Code53LC09  
FDA Product DescriptionSKIN FRESHENERS (SKIN CARE PREPARATIONS)  
Refusal Date09-Dec-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-4813658-7/4/1/P
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.  
LACKS FIRM   502(b)(1), 801(a)(3); MISBRANDING   The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.  
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.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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