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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 BDF-0016033-7/1/1

Manufacturer FEI3002808350
Manufacturer NameTinopal Surgical Corp. (Pvt) Ltd.  
Manufacturer Address line 1Unit #-1, 55/57-B,  
Manufacturer Address line 2Small Industrial Estate  
Manufacturer's CitySialkot, Punjab  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code76EGN  
Importer's Product DescriptionSCISSORS IRIS STR 4.5 SATIN  
Refusal Date02-Sep-2010  
FDA DistrictSWI-DO  
Entry/doc/line/sfx BDF-0016033-7/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
DE IMP GMP   801(a)(1); NON CONFORMING MANUFACTURING PRACTICES   The methods used in, or the facilities or controls used for the manufacture, packing, storage or installation do not conform to the requirements under section 520(f).