- Omron (Dalian) Co., Ltd. (Plant 1)
- Issuing Office:
10903 New Harrpshire Avenue
Silver Spring, MD 20993
JUN 05, 2017
Mr. Isao Ogino, President and CEO
Dear Mr. Ogino:
The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS 273116, dated February 14, 2012). 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.
Ronald L. Swann, M.S.
Acting Director Division of International
Office of Compliance
Center for Devices and Radiological Health
OMRON HEALTHCARE, INC.
1925 W. Field Court, Suite 100
Lake Forest, IL 60045