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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 406-0391418-1/3/1

Manufacturer FEI6412
Manufacturer NameMatsushita Electric Industrial Co Ltd  
Manufacturer Address line 13-2 Minamisemba 4-Chome  
Manufacturer Address line 2Central PO Box 288  
Manufacturer's CityOsaka  
Manufacturer Province/StateOsaka  
Manufacturer Country/AreaJapan  
Product Code95RFX  
Importer's Product DescriptionIC AUDIO RECORDER - FOR EXPORT ONLY  
Refusal Date12-Dec-2006  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 406-0391418-1/3/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
NON STD   536(a),(b); NON STANDARD   It appears that the article fails to comply with applicable standards prescribed under section 534.