Inspections, Compliance, Enforcement, and Criminal Investigations
Quadex Pharmaceuticals, LLC - Close Out Letter 6/7/12
Department of Health and Human Services
|Food and Drug Administration|
Denver District Office
Building 20-Denver Federal Center
P.O. Box 25087
Denver, Colorado 80225-0087
June 7, 2012
Boyd Ronald Johnson
Chief Executive Officer
Quadex Pharmaceuticals, LLC
7070 Union Park Center, #380
Midvale, Utah 84047
Ref:# DEN-12-14-WL Response
Dear Mr. Johnson:
This letter is to acknowledge receipt of your response letter, dated May 21, 2012, to the United States Food and Drug Administration Warning Letter issued to you on May 7, 2012 regarding the marketing and distribution of "Viroxyn Professional."
Your response has been reviewed by the Denver District Office and the Center for Drug Evaluation and Research. While we do not agree with many of the scientific and regulatory positions set forth in your response letter, your short-term and long-term corrective actions, specifically your label corrections as detailed in your response, are deemed to be acceptable.
We note your letter cited other firms and their marketed products. As a matter of policy, we limit communications about the regulatory status of marketed products to those responsible for them, and we do not discuss our enforcement actions except with the targets of those actions. It is the responsibility of each person marketing drug products to comply with all of the requirements of the Food, Drug, and Cosmetic Act and regulations.
Your response will be made part of your firm's official file. The effectiveness of your corrective actions will be verified and fully evaluated during our next inspection of your facility. It is your responsibility to assure that your firm complies with all requirements of federal law, the Food, Drug, and Cosmetic Act and its implementing regulations.
If you have any questions regarding the content of this letter, please contact Thomas R. Berry, Pharm.D., Compliance Officer at (303) 236-3028.
LaTonya M. Mitchell
Denver District Director