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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 BMI-1016449-0/1/1


Manufacturer FEI3007056860
Manufacturer NameKolmar Korea  
Manufacturer Address line 11603-55, Seocho-Dong, Seocho-Gu  
Manufacturer Address line 2  
Manufacturer's CitySEOUL  
Manufacturer Province/StateKR-11  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LD06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date01-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx BMI-1016449-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
COSM COLOR   601(e), 801(a)(3); ADULTERATION   The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).  
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).  
POISONOUS   601(a), 801(a)(3); ADULTERATION   The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.  
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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