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CLOSEOUT LETTER

Nidek Inc 25/08/2015

Nidek Inc - Close Out Letter 8/25/15


Nidek Inc

  

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

 
 Food and Drug Administration
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502

Telephone: (510) 337-6700
FAX: (510) 337-6703

August 25, 2015

VIA UNITED PARCEL SERVICE

Jun Iwata
Chief Operating Officer
Nidek, Inc.
47651 Westinghouse Drive
Fremont, CA 94539

Dear Mr. Iwata:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 434750 dated August 8, 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/

Lawton W. Lum
Director, Compliance Branch