• 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 M76-1739894-8/4/1


Manufacturer FEI3008819311
Manufacturer NameAroma Crystal Therapy  
Manufacturer Address line 12403 Canoe Ave  
Manufacturer Address line 2  
Manufacturer's CityCoquitlam  
Manufacturer Province/StateBC  
Manufacturer Country/AreaCanada  
Product Code53LC06  
FDA Product DescriptionMOISTURIZING (SKIN CARE PREPARATIONS)  
Refusal Date03-Apr-2012  
FDA DistrictSEA-DO  
Entry/doc/line/sfx M76-1739894-8/4/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
UNAPPROVED   505(a), 801(a)(3); UNAPPROVED NEW DRUG   The article appears to be a new drug without an approved new drug application.  
-
-