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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 MH7-7002362-9/23/13


Manufacturer FEI3009688282
Manufacturer NameKgl Services Express  
Manufacturer Address line 107 Bp 439  
Manufacturer Address line 2  
Manufacturer's CityAbidjan  
Manufacturer Province/State  
Manufacturer Country/AreaIvory Coast  
Product Code53LD01  
FDA Product DescriptionCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)  
Refusal Date25-Sep-2012  
FDA DistrictLOS-DO  
Entry/doc/line/sfx MH7-7002362-9/23/13
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DR PACKGNG   502(i) (1), 801(a)(3); MISBRANDING   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a drug and its container is so made, formed, or filled as to be misleading  
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
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