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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 231-2273668-3/1/1

Manufacturer FEI3006480842
Manufacturer NameShenzhen Baoan Guanlan Libao Electr  
Manufacturer Address line 1No. 40 Yuchange Road, Niuhu Old Village  
Manufacturer Address line 2Guanlan, Bao'an  
Manufacturer's CityShenzhen  
Manufacturer Province/State518110  
Manufacturer Country/AreaChina  
Product Code95REP  
Importer's Product Description8LED & LASER FLSHLT BRINKMANN  
Refusal Date29-Nov-2011  
FDA DistrictSWI-DO  
Entry/doc/line/sfx 231-2273668-3/1/1
FDA Sample AnalysisYes  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
FAILS STD   501(e), 801(a)(3); ADULTERATION   The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.  
NO TAG   536(a),(b); NOT CERTIFIED   It appears that the article does not have affixed to it a certification in the form of a label or tag in conformity with section 534(h).