- NIDEK Co., Ltd., Hamacho Plant
10903 New Hampshire Avenue
Silver Spring, MD 20993
MAY 26, 2017
Via United Postal Service
President and Chief Executive Officer
NIDEK Co., Ltd.
34-14 Maehama, Hiroishi-Cho
Gamagori, Aichi 443-0038
Dear Mr. Ozawa:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (#410944, dated September 24, 2013). 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.
Division of International Compliance Operations
Office of Compliance
Center for Devices and Radiological Health