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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 M76-1613208-2/1/1


Manufacturer FEI3007028032
Manufacturer NameYONGKANG BANGLI MEDICAL PRODUCTS CO., LTD  
Manufacturer Address line 1ZNEHGJIA VILLAGE  
Manufacturer Address line 2XIANGZHU TOWN  
Manufacturer's CityYONGKANG CITY  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80FQM  
Importer's Product DescriptionBANDAID  
Refusal Date01-Nov-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx M76-1613208-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
POSS N/STR   501(a)(1); 801(a)(3) ADULTERATION   The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
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