Inspections, Compliance, Enforcement, and Criminal Investigations
Pulse Health, LLC - Close Out Letter 4/15/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave Drive SE, Suite 210
Bothell, WA 98021-4421
April 15, 2013
Christopher L. Marsh, CEO
Pulse Health, LLC
1331 NW Lovejoy Street, Suite 765
Portland, Oregon 97209
Dear Mr. Marsh:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter SEA 12-36, dated September 28, 2012. 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 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.
Charles M. Breen