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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Canon USA, Inc. - Close Out Letter 10/23/13

  

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


October 23, 2013


Mr. Tsuneo Imai, Senior Director and General Manager
Canon USA, Inc.
15975 Alton Parkway
Irvine, CA 92618


Dear Mr. Imai:

The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter WL # 14-13, dated 01/07/13. 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.

 

Sincerely,

/S/

Alonza E. Cruse, Director
Los Angeles District