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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Okamoto Industries Inc. - Close Out Letter 6/7/12

  

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

Public Health Service
Food and Drug Administration
 

10903 New Hampshire Avenue
Silver Spring, MD 20993
 

JUNE 7, 2012

Mr. Yoshiyuki Okamoto
President
Okamoto Industries Inc.
3-27-12, Hongo
Bunkyo-Ku, Tokyo, Japan

Dear Mr. Okamoto:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [WL # 254174 dated December 30, 2011].

Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. As written, your firm's revised MDR Procedure titled "Medical Device Report (MDR) Procedure," QP-QA3-19, Rev. 0, Effective Date: 31-Jan-12. This procedure meets the requirements of 21 CFR 803.17. If your firm wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL:

http://www.fda.gov/Forlndustry/FDAeSubmitter/ucm107903.htm

If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@fda.hhs.gov. 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 yours,

/S/

Anastacia M. Bilek, Ph.D.
Director
Division of Enforcement A
Office of Compliance
Center for Devices and
 Radiological Health