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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 508-0340126-9/7/20


Manufacturer FEI2480525
Manufacturer NameEstee Lauder Inc  
Manufacturer Address line 1767 5th Ave Fl 47th  
Manufacturer Address line 2  
Manufacturer's CityNew York  
Manufacturer Province/StateNY  
Manufacturer Country/AreaUnited States  
Product Code53LC03  
Importer's Product DescriptionREPAIRWEAR LASER FOCUS CARE CREAM 50ML  
Refusal Date07-Jun-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx 508-0340126-9/7/20
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
LABELING   Section 4(a); 801(a)(3) Misbranding   The article appears in violation of FPLA because of its placement, form and/or contents statement.  
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