Inspections, Compliance, Enforcement, and Criminal Investigations
Nickels, Joseph E. - Close Out Letter 2/5/14
Department of Health and Human Services
|Food and Drug Administration|
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
February 5, 2014
Joseph E. Nickels
N4460 Trotter Road
Argyle, Wisconsin 53504-9663
Dear Mr. Nickels:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter MIN 14-02 dated November 18, 2013. 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.
Brian D. Garthwaite, Ph.D.