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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 112-4672703-1/1/1

Manufacturer FEI3008207399
Manufacturer NameJ&C Trading Co Ltd  
Manufacturer Address line 11263-1 Yeongdeokri  
Manufacturer Address line 2  
Manufacturer's CityChungcheongbu  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LH01  
Importer's Product Description479788186673 FOOT PAD HERBAL SACHET & ADHESIVES FOR SKIN CLEANSING PRE  
Refusal Date27-Dec-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-4672703-1/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
FALSE   403(a)(1), 801(a)(3); MISBRANDING   The labeling appears to be false and misleading in any particular.  
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).  
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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