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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 DQ7-0416952-2/2/1/J


Manufacturer FEI3005952467
Manufacturer NameCaregen Co Ltd  
Manufacturer Address line 1690-3 Geumjeong Dong  
Manufacturer Address line 2  
Manufacturer's CityGyeongi-Do  
Manufacturer Province/State  
Manufacturer Country/AreaKorea, Republic Of (South)  
Product Code53LF06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date25-Mar-2013  
FDA DistrictLOS-DO  
Entry/doc/line/sfx DQ7-0416952-2/2/1/J
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
DIRSEXMPT   502(f)(1), 801(a)(3); MISBRANDING   The article appears to lack adequate directions for use, and the article does not appear to be exempt from such requirements.  
FRNMFGREG   510(i); 801(o)   The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.  
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
NO ENGLISH   502(c); 801(a)(3);Misbranding   Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)  
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
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).  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).  
WARNINGS   502(f)(2), 801(a)(3); MISBRANDING   It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.  
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