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CLOSEOUT LETTER

Advanced Sterilization Products 02/06/2016

Advanced Sterilization Products - Close Out Letter 6/2/16


Advanced Sterilization Products

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506

Telephone: 949-608-2900
FAX:          949-608-4415

VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED

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.

Sincerely,

/S/

CDR Steven E. Porter, Jr.
Los Angeles District Director

SP: MMJ

Cc: Alex Gorsky, Chairman and Chief Executive Officer
      One Johnson & Johnson Plaza
      New Brunswick NJ 08933