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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 ASQ-0028069-0/1/1/B


Manufacturer FEI3009045310
Manufacturer NamePendura Inter Laboratories (Asia) Co Ltd  
Manufacturer Address line 16 Prasertmanukrit 29 Yak 10,  
Manufacturer Address line 2  
Manufacturer's CityBangkok  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LD06  
Importer's Product DescriptionNIGH AND DAY CREAM  
Refusal Date20-Oct-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx ASQ-0028069-0/1/1/B
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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