- SUZUKEN CO., LTD. OGUCHI CENTER
Department of Health and Human Services
|Food and Drug Administration|
10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993
SEP 14 2015
Kenz Product Department
Suzuken Co., Ltd ., Oguchi Center
58-1 1 Chome Sotoubo, Niwa-gun
Dear Mr. Iwasaki:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to the Warning Letter (CMS #422711, dated June 11, 2014). Based on the Agency's evaluation, it appears that your firm has 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 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 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.
Carl Fischer, Ph.D.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health