Neitz Instruments Company Ltd.

CLOSEOUT LETTER Neitz Instruments Company Ltd. MARCS-CMS 664336 — October 02, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Medical Devices Recipient: Recipient Name Ms. Takae Nishizawa Recipient Title CEO Neitz Instruments Company Ltd. 4F Ichibancho Court 15-21 Ichibancho JP-13 Chiyoda-Ku , 102-0082 Japan Issuing Office: Center for Devices and Radiological Health United States Secondary Issuing Offices United States Dear Ms. Nishizawa: The United States Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter (CMS # 664336, dated August 25, 2023). Based on our evaluation, it appears that you have addressed the violation(s) 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, /S/ for Malvina B. Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health CC: US AGENT: Takahiro Haruyama Globizz Corp. 1411 W. 190th St., #200 Gardena, California 90248, U.S.A. Email: Register@Globizz.Net Phone 1-310-538-3860 Content current as of: 02/28/2024 Regulated Product(s) Medical Devices