Here's the text of the letter (cut & pasted from the Y! board):
FDA Close Out Letter ~
October 21, 2014
Jonnie R. Williams, CEO
Rock Creek Pharmaceuticals, Inc. (formerly Star Scientific, Inc.)
4470 Cox Rd., Suite 110
Glen Allen, VA 23060
Dear Mr. Williams:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter Case #410094 issued December 20, 2013. Based on our evaluation, it appears that you have addressed the violation(s) 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 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,
Latasha A. Robinson
Branch Chief
Labeling and Dietary Supplement
Compliance Branch
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition
AI
