• 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 ENM-9012178-1/7/3

Manufacturer FEI3008878813
Manufacturer NameSesderma SL  
Manufacturer Address line 1Calle Massamagrell 5  
Manufacturer Address line 2Pol. Industrial Rafelbunyol 3  
Manufacturer's CityRafelbunyol  
Manufacturer Province/StateValencia  
Manufacturer Country/AreaSpain  
Product Code53ED06  
Refusal Date06-Jul-2012  
FDA DistrictSJN-DO  
Entry/doc/line/sfx ENM-9012178-1/7/3
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).