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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 BYA-0120787-7/6/2

Manufacturer FEI3004672062
Manufacturer NameM.M. Enterprise  
Manufacturer Address line 1J B House Borsad (388540)  
Manufacturer Address line 2  
Manufacturer's CityBorsad  
Manufacturer Province/StateGujarat  
Manufacturer Country/AreaIndia  
Product Code53ED99  
Refusal Date02-Jul-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BYA-0120787-7/6/2
FDA Sample AnalysisYes  
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.  
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.