• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail
-

Refusal Details as Recorded in OASIS by FDA

for Refusal AEK-0510815-0/1/1/L


Manufacturer FEI3009726121
Manufacturer NamePornsatit  
Manufacturer Address line 1159/2 Moo 1 T. Vieng  
Manufacturer Address line 2  
Manufacturer's CityA. Thoeng Chiang Rai  
Manufacturer Province/State  
Manufacturer Country/AreaThailand  
Product Code53LI99  
FDA Product DescriptionOTHER SKIN CARE PREPARATIONS, N.E.C.  
Refusal Date26-Oct-2012  
FDA DistrictCIN-DO  
Entry/doc/line/sfx AEK-0510815-0/1/1/L
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
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)  
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).  
-
-