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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 H77-0134654-3/4/2


Manufacturer FEI3008985479
Manufacturer NameHemani International  
Manufacturer Address line 1Plot No. 11, Sector A-IV Karachi 75150  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/StateSindh  
Manufacturer Country/AreaPakistan  
Product Code53EC99  
FDA Product DescriptionOTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.  
Refusal Date15-Jan-2013  
FDA DistrictSWI-DO  
Entry/doc/line/sfx H77-0134654-3/4/2
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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.  
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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