Inspections, Compliance, Enforcement, and Criminal Investigations
WellnessOne World, LLC. - Close Out Letter 6/21/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7210
FAX: (612) 334-4142
June 21, 2012
Timothy Donohue, President
WellnessOne World, LLC.
Lifeline Energetics, Inc.
14000 Sunfish Lake Boulevard NW, Suite 100
Ramsey, Minnesota 55303-2934
Dear Mr. Donohue:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 12-07, dated November 16, 2011. 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 ensure 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.
Demetria L. Lueneburg