Inspections, Compliance, Enforcement, and Criminal Investigations
Nexgen Pharma Inc - Close Out Letter 3/6/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
March 6, 2013
Mr. Steven R. Brown, President & CEO
Nexgen Pharma, Inc.
17802 Gillette Avenue
Irvine, CA 92614
Dear Mr. Brown:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter 45-10 dated September 27, 2010. 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.
Alonza E. Cruse
Los Angeles District Office