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  5. Okamoto Industries, Inc. - 07/21/2016
  1. Warning Letters

CLOSEOUT LETTER

Okamoto Industries, Inc.


Recipient:
Okamoto Industries, Inc.

United States

Issuing Office:

United States


  

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

 
 Food and Drug Administration
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993

JUL 21 2016
 

Kenji Tanaka Ph.D.
Plant Manager
Okamoto Industries, Inc.
No. 1, Nishiyama-ltabashi-Cho
Ryugasaki-Shi, lbaraki-Prefecture 301-0801
Japan

Dear Dr. Tanaka:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS #480261 ) dated November 23, 2015. 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/

Carl Fischer, Ph.D.
Director
Office of Compliance
Center or Devices and
   Radiological Health

Cc: U.S. Agent
      Hisayuki Naito
      Okamoto U.S.A., Inc.
      18 King Street
      Stratford, Connecticut 06615

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