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  5. Steris Isomedix Services - Close Out Letter 11/24/15
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CLOSEOUT LETTER

Steris Isomedix Services Nov 24, 2015

Steris Isomedix Services - Close Out Letter 11/24/15


Steris Isomedix Services

  

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

Food and Drug Administration
 Chicago District
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
Telephone: 312-353-5863

November 24, 2015

VIA UPS NEXT DAY

Mr. Walter M. Rosebrough
President and Chief Executive Officer
STERIS Corporation
5960 Heisley Road
Mentor, OH 44060

Dear Mr. Rosebrough:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, CHI-7-14, dated May 22, 2014. 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/

William R. Weissinger
District Director


cc: Mr. Timothy Zimmerman
     Plant Manager
     STERlS Isomedix Services
     1880 Industrial Drive
     Libertyville, IL 60048