Advanced Sterilization Products - Close Out Letter 6/2/16
- Advanced Sterilization Products
Department of Health and Human Services
|Food and Drug Administration|
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
June 2, 2016
Shlomi Nachman, Company Group, Chairman CSS
Jacqueline Berretta, VP Quality & Compliance CSS
Advanced Sterilization Products, Inc., Division of Ethicon US LLC, Johnson and Johnson Company
33 Technology Drive
Irvine, California 92618-2346
Dear Mr. Nachman and Ms. Berretta:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #10-10 dated March 12, 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.
CDR Steven E. Porter, Jr.
Los Angeles District Director
Cc: Alex Gorsky, Chairman and Chief Executive Officer
One Johnson & Johnson Plaza
New Brunswick NJ 08933