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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 KL1-0177993-4/3/1/B

Manufacturer FEI3010058689
Manufacturer NameSFP Sons  
Manufacturer Address line 1A 24  
Manufacturer Address line 2MEPZ- Special Economic Zone  
Manufacturer's CityTambaram  
Manufacturer Province/StateChennai  
Manufacturer Country/AreaIndia  
Product Code53LC06  
Refusal Date27-Mar-2013  
FDA DistrictNYK-DO  
Entry/doc/line/sfx KL1-0177993-4/3/1/B
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).