U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Sagami Rubber Industries Co., Ltd. - Close Out Letter 5/4/16
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Sagami Rubber Industries Co., Ltd. 04/05/2016

Sagami Rubber Industries Co., Ltd. - Close Out Letter 5/4/16


Sagami Rubber Industries Co., Ltd.

  

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

MAY 04, 2016
 

Shigeo Tadenuma
Director, Healthcare Products Division
Sagami Rubber Industries Co. , Ltd.
2-1 , Moto-Cho, Atsugi-Shi
Kanagawa-Ken 243-0002
Japan

Dear Mr. Tadenuma:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (WL #481765, dated November 24, 2015). Based on our evaluation, it appears that you have
addressed the violation 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 yours,

/S/

Carl Fischer, Ph.D.
Director
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health
 

cc:
U.S. Agent
David P. Mayer
Mayer Laboratories
710 West Napa Street, Suite 4
Sonoma, California 95476