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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 582-3697100-8/1/1


Manufacturer FEI3002291120
Manufacturer NameDodhy Brothers  
Manufacturer Address line 1Al-Hadi Town, Defence Road  
Manufacturer Address line 2  
Manufacturer's CitySialkot  
Manufacturer Province/State  
Manufacturer Country/AreaPakistan  
Product Code79MDM  
FDA Product DescriptionINSTRUMENT, MANUAL, GENERAL SURGICAL  
Refusal Date20-Aug-2003  
FDA DistrictPHI-DO  
Entry/doc/line/sfx 582-3697100-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DEVICEGMPS   501(h), 801(a)(1); ADULTERATION   The methods, facilities, or controls used for the article's manufacture, packing, storage, or installation do not conform with applicable requirements under section 520(f)(1) or a condition prescribed by an order under section 520(f)(2).  
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