Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail
-

Adamis Pharmaceuticals Close out Letter 2/15/11

   

Department of Health and Human Services logoDepartment of Health and Human Services

 Public Health Service
Food and Drug Administration
  Silver Spring, MD 20993 

February 15, 2011


Dennis J. Carlo, PhD
President and CEO
Adamis Pharmaceuticals
2658 Del Mar Heights Road, suite 555
Del Mar, California 92014


Dear Mr. Carlo:


The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter dated June 9, 2010. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.


This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your client's state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.


Sincerely,

/S/
Michael M. Levy, J ., Esq.
Director
Division of New Drugs and Labeling Compliance
Office of Compliance
Food and Drug Administration

-
-