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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 112-3973510-8/1/1

Manufacturer FEI3009117824
Manufacturer NameParlain Co Ltd  
Manufacturer Address line 121f Comml Bldgno.1 Mongkok Road  
Manufacturer Address line 2  
Manufacturer's CityKowloonkowloon  
Manufacturer Province/State  
Manufacturer Country/AreaHong Kong SAR  
Product Code53YY99  
Importer's Product Description853559919644 SKIN PERFECT DERMAL LIFT NEEDLE  
Refusal Date05-Oct-2011  
FDA DistrictSEA-DO  
Entry/doc/line/sfx 112-3973510-8/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
CSTIC LBLG   602(a) and/or (b), and/or (c), 801(a)(3); MISBRANDING   The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.