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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Sagami Rubber Industries Co., Ltd. - Close Out Letter 9/21/11


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


SEP 21 2011

Mr. Ichiro Oato
Sagami Rubber Industries Co., Ltd.
2-1, Moto-Cho
Atsugi City
Kanagawa-Prefecture 243-0002,

Dear Mr. Oato:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter #136571, dated November 24, 2010. 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 yours,


Steven D. Silverman
Office of Compliance
Center for Devices and
      Radiological Health


Yoshiaki Kawaguchi
Director/General Manager
Sagami Manufacturers Sdn. Bhd.
Plot 29, Lorong Bemban 4
Estet Perindustrain Bemban
Jalan Bemban, 31000 Batu Gajah
Perak, Malaysia

Mr. Masataka Takeda
Factory Manager, Managing Director
Sagami Rubber Industries Co., Ltd.
2-1, Moto-Cho,
Atsugi City,
Kanagawa-Prefecture 243-0002,

Grant Burt
Sagami Europe
Les Cedres
Route de Molles
Cusset 03300