Inspections, Compliance, Enforcement, and Criminal Investigations
PruTect Rx - Close Out Letter 8/29/13
Department of Health and Human Services
|Food and Drug Administration|
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
August 29, 2013
Attn: Chad Prusmack, M.D.
9457 South University Blvd.
Highlands Ranch, CO 80126
RE: Food and Drug Administration (FDA) Warning Letter Close-Out Letter
Dear Dr. Prusmack:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [DEN-12-18-WL, dated August 27, 2012]. 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.
Nancy G. Schmidt