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CLOSEOUT LETTER

OEM Systems Co., Ltd 09/02/2015

OEM Systems Co., Ltd - Close Out Letter 2/9/15


OEM Systems Co., Ltd

  

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

Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

FEB 09, 2015

 

Mr. Kenji Sugimura, President
OEM Systems Co., Ltd
84, Mekawa Makishima-Cho
Uji-Shi, Kyoto, 611-0041 Japan


Dear Mr. Sugimura:

The Food and Drug Administration has completed an evaluation of OEM Systems Co., Ltd's corrections and corrective actions in response to our Warning Letter (CMS case# 156054 on 02/03/2011). 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/

James L. Woods
Deputy Director Patient Safety
  And Product Quality
Office of In Vitro Diagnostics and
  Radiological Health
Center for Devices and
  Radiological Health