Inspections, Compliance, Enforcement, and Criminal Investigations

Shima Laboratories Co., Ltd. - Close Out Letter 4/6/17

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

APR 06, 2017

Dr. Masakatsu Hashimoto
President & CEO
SHIMA Laboratories Co., Ltd
1-16-4, Maeno-Cho, Itabashi-Ku
Tokyo, 174-0063 Japan

Dear Dr. Hashimoto:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter [ CMS#418378] dated March 21, 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 ofthese 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/

Donald J. St. Pierre
Acting Deputy Director for Patient Safety
   and Product Quality
Office ofln Vitro Diagnostics and Radiological Health
Center for Device and Radiological Health

 

Page Last Updated: 04/14/2017
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