Molteno Ophthalmic Limited

CLOSEOUT LETTER Molteno Ophthalmic Limited MARCS-CMS 450427 — August 02, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: United States Postal Service Product: Medical Devices Recipient: Recipient Name Tess E.S. Molteno Recipient Title Managing Director Molteno Ophthalmic Limited 152 Frederick Street Dunedin 9016 New Zealand Issuing Office: Center for Devices and Radiological Health 10903 New Hampshire Avenue Silver Spring , MD 20993 United States Dear Mrs. Molteno: The Food and Drug Administration. (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter (CMS 450427, dated February 27, 2015). 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 yours, /S/ Ronald L. Swann, M.S. Acting Director Division of International Compliance Operations Office of Compliance Center for Devices and Radiological Health Content current as of: 08/09/2019 Regulated Product(s) Medical Devices