United Producers, Inc. - Close Out Letter 8/19/15
- United Producers, Inc.
Department of Health and Human Services
|Public Health Service|
|Food and Drug Administration|
300 River Place
Detroit, MI 48207
August 19, 2015
Dennis Bolling, President & CEO
United Producers, Inc.
8351 North High Street, Suite 250
Columbus, OH 43235
Dear Mr. Balling:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 2015-DET-11, dated June May 21, 2015. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Any 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 actions should violations be observed during a subsequent inspection or through other means.
If you have any questions, I can be reached at (313)393-8150.
Detroit District Office