Inspections, Compliance, Enforcement, and Criminal Investigations
Matrixx Initiatives Inc - Close Out Letter 5/30/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
May 30, 2013
Mr. Tim L. Clarot, Vice President, R&D/Product Quality
Matrixx Initiatives, Inc.
8515 E. Anderson Dr.
Scottsdale, AZ 85255
Dear Mr. Clarot:
The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL # 45-11, dated 06/03/11. 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.
Alonza E. Cruse, Director
Los Angeles District