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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 AP4-0033181-9/3/1

Manufacturer FEI3003857201
Manufacturer NamePak Best Group  
Manufacturer Address line 1Flat No 4, Main Korangi Rd  
Manufacturer Address line 2  
Manufacturer's CityKarachi  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code66VAR99  
Importer's Product DescriptionENO: SODIUM BICARONUTE  
Refusal Date08-Aug-2003  
FDA DistrictLOS-DO  
Entry/doc/line/sfx AP4-0033181-9/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).